PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer

NCT01723774

Last updated date
Study Location
University of Alabama
Birmingham, Alabama, 35233, United States
Contact
314-362-9383

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

below must be met in addition to the pre-registration criteria -Current
use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors (i.e.
grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole,
erythromycin, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir,
lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delavirdine)
or inducers (i.e. dexamethasone, glucocorticoids, progesterone, rifampin, phenobarbital,
St. John's wort)


PIK3CA Wild Type Inclusion


- Clinical T2-T4c, any N, M0 invasive ER+ (Allred Score of 6-8) and HER2 negative (0 or
1+ by IHC or FISH negative for amplification) breast cancer, by AJCC 7th edition
clinical staging, with the goal being surgery to completely excise the tumor in the
breast and the lymph node. Note: Patients with invasive ER+ (Allred Score of 6-8)
HER2- breast cancer or DCIS in the contralateral breast the patient are eligible


- For the PIK3CA wild type cohort: tumor PIK3CA mutation absent. Note that if a patient
did not have sufficient research tissue for PIK3CA sequencing at pre-registration or
if PIK3CA sequencing result is delayed, she could be registered and enrolled on the
PD991 trial without assigning to a particular cohort at the time of enrollment. PIK3CA
sequencing will be performed in the future on tumors collected at subsequent time
points to assign the treatment cohort or when the PIK3CA sequencing data is available


- For the endocrine resistant cohort: Ki67 > 10% by central testing at Washington
University AMP laboratory from a tumor biopsy performed after at least 2 weeks on
neoadjuvant endocrine therapy. Note that prior neoadjuvant endocrine therapy could
include any endocrine therapy (including aromatase inhibitor, tamoxifen, fulvestrant)
alone or in combination, or endocrine therapy in combination with any investigational
agent that is not a Cdk 4/6 inhibitor


*Patients who had a Day 17 Ki67 > 10% from the NCI9170 trial are eligible for the
endocrine resistant cohort


- Female >18 years of age


- ECOG performance status of 0, 1 or 2


- Life expectancy > 4 months


- If premenopausal, patient must be willing to comply with pregnancy requirements


- Adequate organ and marrow function:


- leukocytes ≥ 3,000/mcL


- absolute neutrophil count ≥ 1,500/mcL


- platelets ≥ 100,000/mcL


- total bilirubin ≤ ULN


- AST(SGOT)/ and ALT(SGPT) < 2.5 X ULN


- Creatinine ≤ ULN


- In premenopausal women, serum estradiol level in postmenopausal range ≤ 7 days prior
to registration.


- Able to understand and willing to sign an IRB-approved written informed consent
document


Exclusion


- Prior treatment of this cancer including: Surgery, Radiation therapy, Chemotherapy,
Biotherapy, Hormonal therapy, Investigational agent prior to study entry


- Receiving any other investigational agents


- Prior therapy with any Cdk4 inhibitor


- Any of the following in the previous 6 months: myocardial infarction, severe/unstable
angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure,
cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism


- Uncontrolled intercurrent illness including, but not limited to: ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris,
uncontrolled symptomatic cardiac arrhythmia, psychiatric illness/social situations
that would limit compliance with study requirements


- Pregnant/nursing


- Unwilling to employ adequate contraception


- Known HIV-positive on combination antiretroviral therapy


- Evidence of inflammatory cancer


- Known metastatic disease


- Current use of anticoagulation therapy


- Previous excisional biopsy of the breast cancer or sentinel lymph node biopsy


- Any condition that impairs patient's ability to swallow PD 0332991 tablets (e.g.,
gastrointestinal tract disease resulting in an inability to take oral medication or a
requirement for IV alimentation, prior surgical procedures affecting absorption)


- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to PD 0332991 or other agents used in the study


- Corrected QT interval >470 msec


- Current use or anticipated need for food or drugs that are known strong CYP3A4
inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole,
posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir,
ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone,
diltiazem, and delavirdine) or inducers (i.e. dexamethasone, glucocorticoids,
progesterone, rifampin, phenobarbital, St. John's wort)


Endocrine Resistant Inclusion


- Clinical T2-T4c at diagnosis or screening, any N, M0 invasive ER+ (Allred Score at
least 3 or > 1% ER positivity) and HER2 negative (0 or 1+ by IHC or FISH negative or
equivocal) breast cancer, by AJCC 7th edition clinical staging, with the goal being
surgery to completely excise the tumor in the breast and the lymph node. Note:
Patients with invasive breast cancer that is ER pos, HER2 neg or equivocal or DCIS in
the contralateral breast are eligible; multi-focal diseases are not excluded. The
dominant lesion will be followed per protocol


- Ki67 > 10% by central testing at Washington University AMP laboratory from a tumor
biopsy performed after at least 2 weeks on neoadjuvant endocrine therapy. If Ki67 is >
10% by local testing, the Ki67 slide and H&E slide need to be reviewed by the study
pathologist to confirm eligibility (discuss with Study Chair). For patients external
to Washington University, please contact the Washington University coordinator by
email so that a screening ID# can be assigned prior to shipment of the slides


- Female ≥ 18 years of age


- ECOG performance status of 0, 1 or 2


- Pre- or post-menopausal women are eligible. If premenopausal, patient must be willing
to comply with pregnancy requirements and agrees with GnRH agonist therapy for ovarian
suppression during the study


- Adequate organ and marrow function:


- Leukocytes ≥ 3,000/mcL


- Absolute neutrophil count ≥ 1,500/mcL


- Platelets ≥ 100,000/mcL


- Total bilirubin ≤ ULN


- AST(SGOT)/ and ALT(SGPT) < 2.5 X ULN


- Creatinine ≤ ULN


- Able to understand and willing to sign an IRB-approved written informed consent
document


Exclusion


- Prior treatment of this cancer including: Surgery, Radiation, Chemotherapy


- Receiving any other investigational agents


- Prior therapy with Cdk4 inhibitor


- Any of the following in the previous 6 months: myocardial infarction, severe/unstable
angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure,
cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism


- Uncontrolled intercurrent illness including, but not limited to: ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris,
uncontrolled symptomatic cardiac arrhythmia, psychiatric illness/social situations
that would limit compliance with study requirements


- Pregnant/nursing


- Unwilling to employ adequate contraception


- Known HIV-positive on combination antiretroviral therapy


- Known metastatic disease


- Current use of anticoagulation therapy


- Previous excisional biopsy of the breast cancer or sentinel lymph node biopsy


- Any condition that impairs patient's ability to swallow PD 0332991 tablets (e.g.,
gastrointestinal tract disease resulting in an inability to take oral medication or a
requirement for IV alimentation, prior surgical procedures affecting absorption)


- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to PD 0332991 or other agents used in the study


- Corrected QT interval >470 msec


- Current use or anticipated need for food or drugs that are known strong CYP3A4
inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole,
posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir,
ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone,
diltiazem, and delavirdine) or inducers (i.e. dexamethasone, glucocorticoids,
progesterone, rifampin, phenobarbital, St. John's wort)


Adjuvant Inclusion


- Derived benefit from PD 0332991 in the neoadjuvant setting in this trial. This
includes the 26 patients who achieved complete cell cycle arrest only after the
addition of PD 0332991 (C1D1 Ki67 >2.7% and C1D15 Ki67 ≤ 2.7%) from the main study
(PIK3CA WT, mutant, or unknown cohorts) as well as any patients who have a Ki67 ≤ 10%
on C1D15 biopsy in the endocrine resistant cohort


- ECOG performance status of 0, 1 or 2


- Premenopausal, patient must be willing to comply with pregnancy requirements laid out


- Adequate organ and marrow function


- leukocytes ≥ 3,000/mcL


- absolute neutrophil count ≥ 1,500/mcL


- platelets ≥ 100,000/mcL


- total bilirubin ≤ ULN


- AST(SGOT)/ and ALT(SGPT) ≤ 2.5 X ULN


- Creatinine ≤ ULN


- Underwent surgery of the breast and axilla for curative intent


- At least 4 weeks post completion of adjuvant chemotherapy and radiation therapy if
indicated


- Patients who already started on adjuvant hormonal therapy are eligible under the
following conditions:


- For the 26 patients who enrolled in the initial cohorts and derived benefit from
neoadjuvant PD 0332991 (C1D1 Ki67 >2.7% and C1D15 Ki67 ≤ 2.7%), adjuvant PD
0332991 should be initiated as soon as possible if adjuvant hormonal therapy has
been initiated and the patient has completed radiation if indicated


- For patients who enrolled in the endocrine resistant cohort and derived benefit
from neoadjuvant PD 0332991 (C1D15 Ki67 ≤ 10%), adjuvant PD 0332991 should be
initiated within 6 months or sooner after initation of adjuvant hormonal therapy


- Able to understand and willing to sign an IRB-approved written informed consent
document


Exclusion


- Any of the following in the previous 6 months: myocardial infarction, severe/unstable
angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure,
cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism


- Uncontrolled intercurrent illness including, but not limited to: ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris,
uncontrolled symptomatic cardiac arrhythmia, ssychiatric illness/social situations
that would limit compliance with study requirements


- Pregnant/nursing


- Unwilling to employ adequate contraception


- Known HIV-positive on combination antiretroviral therapy. -Known metastatic disease


- Any condition that impairs patient's ability to swallow PD 0332991 tablets (e.g.,
gastrointestinal tract disease resulting in an inability to take oral medication or a
requirement for IV alimentation, prior surgical procedures affecting absorption)


- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to PD 0332991 or other agents used in the study


- Corrected QT interval >470 msec


- Current use or anticipated need for food or drugs that are known strong CYP3A4
inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole,
posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir,
ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone,
diltiazem, and delavirdine) or inducers (i.e. dexamethasone, glucocorticoids,
progesterone, rifampin, phenobarbital, St. John's wort)

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Advanced Information
Descriptive Information
Brief Title  ICMJE PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer
Official Title  ICMJE A Phase II Trial of Neoadjuvant PD 0332991, a Cyclin-Dependent Kinase (Cdk) 4/6 Inhibitor, in Combination With Anastrozole in Women With Clinical Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer
Brief Summary A Phase II study to investigate the potential utility of PD 0332991 in the treatment of early stage ER+ Human epidermal growth factor receptor 2 (HER2)- breast cancer, to investigate whether the combination of PD 0332991 and anastrozole is able to: 1) improve the pathologic complete response rate when compared to the historical control of single agent aromatase inhibitors, 2) result in fewer patients with on therapy Ki67>10% compared to historical control.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: PD0332991
  • Drug: Anastrozole
    Other Name: Arimidex®
  • Drug: Goserelin
    Other Names:
    • Zoladex®
    • Decapeptide I
  • Procedure: Surgery (standard of care)
    -Breast and axillary lymph node surgery
  • Procedure: Tumor biopsy
Study Arms  ICMJE
  • Experimental: Arm 1: PIK3CA Wild Type Cohort
    • Tumor biopsy for testing/research at baseline and Cycle 1 Day 15
    • Cycle 0 is 28 days of anastrozole PO daily and, if premenopausal, goserelin SC every 28 days.
    • Cycles 1-5: PD 0332991 combined with anastrozole (and goserelin if premenopausal) is to be (4) 28-day cycles followed by a 5th cycle of 10-12 days duration consisting of daily PD 0332991 and anastrozole (last dose day before surgery)
    • Standard surgery will be performed per institutional standards 2-4 weeks following the completion of Cycle 4 in those who did not receive Cycle 5. In patients who receive Cycle 5, surgery occurs on Day 11, 12, or 13 of Cycle 5.
    • Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned.
    Interventions:
    • Drug: PD0332991
    • Drug: Anastrozole
    • Drug: Goserelin
    • Procedure: Surgery (standard of care)
    • Procedure: Tumor biopsy
  • Experimental: Arm 2: PIK3CA Mutant Type Cohort
    • Tumor biopsy for testing/research at baseline and Cycle 1 Day 15
    • Cycle 0 is 28 days of anastrozole PO daily and, if premenopausal, goserelin SC every 28 days.
    • Cycles 1-5: PD 0332991 combined with anastrozole (and goserelin if premenopausal) is to be (4) 28-day cycles followed by a 5th cycle of 10-12 days duration consisting of daily PD 0332991 and anastrozole (last dose day before surgery)
    • Standard surgery will be performed per institutional standards 2-4 weeks following the completion of Cycle 4 in those who did not receive Cycle 5. In patients who receive Cycle 5, surgery occurs on Day 11, 12, or 13 of Cycle 5.
    • Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned.
    Interventions:
    • Drug: PD0332991
    • Drug: Anastrozole
    • Drug: Goserelin
    • Procedure: Surgery (standard of care)
    • Procedure: Tumor biopsy
  • Experimental: Arm 3: Endocrine Resistant Cohort
    • Tumor biopsy for testing/research at baseline and Cycle 1 Day 15
    • Cycles 1-5: PD 0332991 combined with anastrozole (and goserelin if premenopausal) is to be (4) 28-day cycles followed by a 5th cycle of 10-12 days duration consisting of daily PD 0332991 and anastrozole (last dose day before surgery)
    • Standard surgery will be performed per institutional standards 2-4 weeks following the completion of Cycle 4 in those who did not receive Cycle 5. In patients who receive Cycle 5, surgery occurs on Day 11, 12, or 13 of Cycle 5.
    • Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned.
    Interventions:
    • Drug: PD0332991
    • Drug: Anastrozole
    • Drug: Goserelin
    • Procedure: Surgery (standard of care)
    • Procedure: Tumor biopsy
Publications * Bagegni N, Thomas S, Liu N, Luo J, Hoog J, Northfelt DW, Goetz MP, Forero A, Bergqvist M, Karen J, Neumüller M, Suh EM, Guo Z, Vij K, Sanati S, Ellis M, Ma CX. Serum thymidine kinase 1 activity as a pharmacodynamic marker of cyclin-dependent kinase 4/6 inhibition in patients with early-stage breast cancer receiving neoadjuvant palbociclib. Breast Cancer Res. 2017 Nov 21;19(1):123. doi: 10.1186/s13058-017-0913-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2017)
87
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2012)
29
Estimated Study Completion Date  ICMJE April 30, 2027
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Pre-registration PIK3CA Mutant Inclusion

  • Clinical T2-T4c, any N, M0 invasive ER+ (Allred Score of 6-8) and HER2 negative (0 or 1+ by IHC or FISH negative for amplification) breast cancer, by AJCC 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node. Note: Patients with invasive ER+ (Allred Score of 6-8) HER2- breast cancer or DCIS in the contralateral breast the patient are eligible
  • Female ?18 years of age
  • ECOG performance status of 0, 1 or 2
  • Life expectancy > 4 months
  • Premenopausal, patient must be willing to comply with pregnancy requirements
  • Adequate organ and marrow function

    • leukocytes ? 3,000/mcL
    • absolute neutrophil count ? 1,500/mcL
    • platelets ? 100,000/mcL
    • total bilirubin ? ULN
    • AST(SGOT)/ and ALT(SGPT) < 2.5 X ULN
    • Creatinine ? ULN
  • Able to understand and willing to sign an IRB-approved written informed consent document

Exclusion

  • Prior treatment of this cancer including: surgery, radiation, chemotherapy, biotherapy, hormonal therapy, investigational agent prior to study entry
  • Receiving any investigational agents
  • Prior therapy with any Cdk4 inhibitor
  • Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism
  • Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled symptomatic cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant/nursing
  • Unwilling to employ adequate contraception
  • Known HIV-positive on combination antiretroviral therapy
  • Evidence of inflammatory cancer
  • Known metastatic disease
  • Current use of anticoagulation therapy
  • Previous excisional biopsy of the breast cancer or sentinel lymph node biopsy
  • Any condition that impairs patient's ability to swallow PD 0332991 tablets (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to PD 0332991 or other agents used in the study
  • Corrected QT interval >470 msec

Registration PIK3CA Mutant Inclusion The criteria below must be met in addition to the pre-registration criteria, except treatment with endocrine therapy for this cancer is allowed prior to registration

  • PIK3CA mutant cohort: tumor PIK3CA mutation present
  • Premenopausal women, serum estradiol level in postmenopausal range ? 7 days prior to registration

Exclusion Criteria below must be met in addition to the pre-registration criteria -Current use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delavirdine) or inducers (i.e. dexamethasone, glucocorticoids, progesterone, rifampin, phenobarbital, St. John's wort)

PIK3CA Wild Type Inclusion

  • Clinical T2-T4c, any N, M0 invasive ER+ (Allred Score of 6-8) and HER2 negative (0 or 1+ by IHC or FISH negative for amplification) breast cancer, by AJCC 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node. Note: Patients with invasive ER+ (Allred Score of 6-8) HER2- breast cancer or DCIS in the contralateral breast the patient are eligible
  • For the PIK3CA wild type cohort: tumor PIK3CA mutation absent. Note that if a patient did not have sufficient research tissue for PIK3CA sequencing at pre-registration or if PIK3CA sequencing result is delayed, she could be registered and enrolled on the PD991 trial without assigning to a particular cohort at the time of enrollment. PIK3CA sequencing will be performed in the future on tumors collected at subsequent time points to assign the treatment cohort or when the PIK3CA sequencing data is available
  • For the endocrine resistant cohort: Ki67 > 10% by central testing at Washington University AMP laboratory from a tumor biopsy performed after at least 2 weeks on neoadjuvant endocrine therapy. Note that prior neoadjuvant endocrine therapy could include any endocrine therapy (including aromatase inhibitor, tamoxifen, fulvestrant) alone or in combination, or endocrine therapy in combination with any investigational agent that is not a Cdk 4/6 inhibitor

    *Patients who had a Day 17 Ki67 > 10% from the NCI9170 trial are eligible for the endocrine resistant cohort

  • Female >18 years of age
  • ECOG performance status of 0, 1 or 2
  • Life expectancy > 4 months
  • If premenopausal, patient must be willing to comply with pregnancy requirements
  • Adequate organ and marrow function:

    • leukocytes ? 3,000/mcL
    • absolute neutrophil count ? 1,500/mcL
    • platelets ? 100,000/mcL
    • total bilirubin ? ULN
    • AST(SGOT)/ and ALT(SGPT) < 2.5 X ULN
    • Creatinine ? ULN
  • In premenopausal women, serum estradiol level in postmenopausal range ? 7 days prior to registration.
  • Able to understand and willing to sign an IRB-approved written informed consent document

Exclusion

  • Prior treatment of this cancer including: Surgery, Radiation therapy, Chemotherapy, Biotherapy, Hormonal therapy, Investigational agent prior to study entry
  • Receiving any other investigational agents
  • Prior therapy with any Cdk4 inhibitor
  • Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism
  • Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled symptomatic cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant/nursing
  • Unwilling to employ adequate contraception
  • Known HIV-positive on combination antiretroviral therapy
  • Evidence of inflammatory cancer
  • Known metastatic disease
  • Current use of anticoagulation therapy
  • Previous excisional biopsy of the breast cancer or sentinel lymph node biopsy
  • Any condition that impairs patient's ability to swallow PD 0332991 tablets (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to PD 0332991 or other agents used in the study
  • Corrected QT interval >470 msec
  • Current use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delavirdine) or inducers (i.e. dexamethasone, glucocorticoids, progesterone, rifampin, phenobarbital, St. John's wort)

Endocrine Resistant Inclusion

  • Clinical T2-T4c at diagnosis or screening, any N, M0 invasive ER+ (Allred Score at least 3 or > 1% ER positivity) and HER2 negative (0 or 1+ by IHC or FISH negative or equivocal) breast cancer, by AJCC 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node. Note: Patients with invasive breast cancer that is ER pos, HER2 neg or equivocal or DCIS in the contralateral breast are eligible; multi-focal diseases are not excluded. The dominant lesion will be followed per protocol
  • Ki67 > 10% by central testing at Washington University AMP laboratory from a tumor biopsy performed after at least 2 weeks on neoadjuvant endocrine therapy. If Ki67 is > 10% by local testing, the Ki67 slide and H&E slide need to be reviewed by the study pathologist to confirm eligibility (discuss with Study Chair). For patients external to Washington University, please contact the Washington University coordinator by email so that a screening ID# can be assigned prior to shipment of the slides
  • Female ? 18 years of age
  • ECOG performance status of 0, 1 or 2
  • Pre- or post-menopausal women are eligible. If premenopausal, patient must be willing to comply with pregnancy requirements and agrees with GnRH agonist therapy for ovarian suppression during the study
  • Adequate organ and marrow function:

    • Leukocytes ? 3,000/mcL
    • Absolute neutrophil count ? 1,500/mcL
    • Platelets ? 100,000/mcL
    • Total bilirubin ? ULN
    • AST(SGOT)/ and ALT(SGPT) < 2.5 X ULN
    • Creatinine ? ULN
  • Able to understand and willing to sign an IRB-approved written informed consent document

Exclusion

  • Prior treatment of this cancer including: Surgery, Radiation, Chemotherapy
  • Receiving any other investigational agents
  • Prior therapy with Cdk4 inhibitor
  • Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism
  • Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled symptomatic cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant/nursing
  • Unwilling to employ adequate contraception
  • Known HIV-positive on combination antiretroviral therapy
  • Known metastatic disease
  • Current use of anticoagulation therapy
  • Previous excisional biopsy of the breast cancer or sentinel lymph node biopsy
  • Any condition that impairs patient's ability to swallow PD 0332991 tablets (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to PD 0332991 or other agents used in the study
  • Corrected QT interval >470 msec
  • Current use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delavirdine) or inducers (i.e. dexamethasone, glucocorticoids, progesterone, rifampin, phenobarbital, St. John's wort)

Adjuvant Inclusion

  • Derived benefit from PD 0332991 in the neoadjuvant setting in this trial. This includes the 26 patients who achieved complete cell cycle arrest only after the addition of PD 0332991 (C1D1 Ki67 >2.7% and C1D15 Ki67 ? 2.7%) from the main study (PIK3CA WT, mutant, or unknown cohorts) as well as any patients who have a Ki67 ? 10% on C1D15 biopsy in the endocrine resistant cohort
  • ECOG performance status of 0, 1 or 2
  • Premenopausal, patient must be willing to comply with pregnancy requirements laid out
  • Adequate organ and marrow function

    • leukocytes ? 3,000/mcL
    • absolute neutrophil count ? 1,500/mcL
    • platelets ? 100,000/mcL
    • total bilirubin ? ULN
    • AST(SGOT)/ and ALT(SGPT) ? 2.5 X ULN
    • Creatinine ? ULN
  • Underwent surgery of the breast and axilla for curative intent
  • At least 4 weeks post completion of adjuvant chemotherapy and radiation therapy if indicated
  • Patients who already started on adjuvant hormonal therapy are eligible under the following conditions:

    • For the 26 patients who enrolled in the initial cohorts and derived benefit from neoadjuvant PD 0332991 (C1D1 Ki67 >2.7% and C1D15 Ki67 ? 2.7%), adjuvant PD 0332991 should be initiated as soon as possible if adjuvant hormonal therapy has been initiated and the patient has completed radiation if indicated
    • For patients who enrolled in the endocrine resistant cohort and derived benefit from neoadjuvant PD 0332991 (C1D15 Ki67 ? 10%), adjuvant PD 0332991 should be initiated within 6 months or sooner after initation of adjuvant hormonal therapy
  • Able to understand and willing to sign an IRB-approved written informed consent document

Exclusion

  • Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism
  • Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled symptomatic cardiac arrhythmia, ssychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant/nursing
  • Unwilling to employ adequate contraception
  • Known HIV-positive on combination antiretroviral therapy. -Known metastatic disease
  • Any condition that impairs patient's ability to swallow PD 0332991 tablets (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to PD 0332991 or other agents used in the study
  • Corrected QT interval >470 msec
  • Current use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delavirdine) or inducers (i.e. dexamethasone, glucocorticoids, progesterone, rifampin, phenobarbital, St. John's wort)
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cynthia Ma, M.D., Ph.D.314-362-9383[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01723774
Other Study ID Numbers  ICMJE 201301106
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Cynthia Ma, M.D., Ph.D.Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP