Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors

NCT02028507

Last updated date
Study Location
Universitätsklinik für Innere Medizin III
Salzburg, , 5020, Austria
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. The patient has signed the informed consent document.

2. a) Patients in cohort 1: Females with histologically confirmed MBC whose disease is resistant to previous non-steroidal aromatase inhibitors (letrozole or anastrozole) b) Patients in cohort 2: Females with histologically confirmed MBC whose disease was resistant to previous aromatase inhibitors (exemestane, letrozole or anastrozole).

Resistance is defined as: Recurrence while on or within 12 months after the end of adjuvant treatment with NSAI/AI or Progression while on or within 1 month after the end of treatment with NSAI/AI for advanced disease.

3. Previous chemotherapy is permitted either in the (neo) adjuvant setting and/or first line therapy for MBC (chemotherapy administered as "second adjuvant therapy" for locoregional recurrence should be considered as first line chemotherapy for MBC).

4. It is not mandatory to have exemestane, letrozole or anastrozole as the most recent treatment before randomization but recurrence or progression of breast cancer while receiving (or immediately after the enf of) the most recent systemic therapy has to be documented before randomization.

5. Hormonal receptor positive (HR+) breast cancer based on local laboratory determination. HR+ defined as major or equal to 1 percent positive cells by Immunohistochemistry (IHC) for ER and/or Progesterone Receptor (PgR).

6. Documented HER2 negative breast cancer based on local laboratory determination on most recent tumor biopsy. HER2 negative tumor is determined as IHC score 0 or 1+ or negative by ISH (FISH/Chromogenic In Situ Hybridization (CISH)/SISH) defined as a HER2/CEP17 ratio minor to 2 or for single probe assessment a HER2 copy number minor to 4.

7. Measurable disease or at least one bone lesion, lytic or mixed (lytic+blastic), which has not been previously irradiated and is assessable by CT/MRI in the absence of measurable disease according to RECIST 1.1 criteria.

8. Patient is at least 18 years of age.

9. Eastern Cooperative Oncology Group (ECOG) Performance Status minor or equal to 1.

10. Life expectancy major or equal to 12 weeks.

11. Adequate organ and bone marrow function.

12. Postmenopausal women defined as women with:

Prior bilateral surgical oophorectomy, or Age > 60 years, or Age < 60 years and medically confirmed post-menopausal status defined as spontaneous cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause or follicle-stimulating hormone (FSH) and estradiol blood levels in their respective postmenopausal ranges

13. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 Grade minor or equal to 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator´s discretion).

14. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Have received more than 1 prior chemotherapy regimen for MBC. (NOTE: Chemotherapy
administered as "second adjuvant therapy" for locoregional recurrence should be
considered one prior chemotherapy for MBC).Other previous anticancer endocrine
treatments for advanced disease are allowed.


2. Patients with advanced, symptomatic, visceral spread that are at risk of
life-threatening complications in the short term (including patients with massive
uncontrolled effusions (pleural, pericardial, peritoneal), pulmonary lymphangitis and
over 50% liver involvement).


3. Known active uncontrolled or symptomatic central nervous system (CNS) metastases,
carcinomatous meningitis or leptomeningeal disease as indicated by clinical symptoms,
cerebral edema, and/or progressive growth. Patients with a history of CNS metastases
or cord compression are eligible if they have been definitively treated with local
therapy (eg, radiotherapy,) and are clinically stable off anticonvulsants and steroids
for at least 4 weeks before randomization.


4. Prior treatment with any CDK4/6, mTOR or PI3K inhibitor (any agent whose mechanism of
action is to inhibit the PI3 kinase-mTOR pathway) or capecitabine.


5. a) Patients included in cohort 1: Prior treatment with exemestane in the metastatic
setting. If the patient has received exemestane in the adjuvant setting and developed
MBC, she will be eligible for the study provided:


- She has received letrozole/anastrozole as first-line MBC and progressed.


- At least 1 year has elapsed since the end of adjuvant exemestane treatment. b)
Patients included in Cohort 2: Prior treatment with fulvestrant in the metastatic
setting. If the patient has received fulvestrant in the adjuvant setting and
developed MBC, she will be eligible for the study provided:


- She has received letrozole/anastrozole as first-line MBC and progressed.


- At least 1 year has elapsed since the end of adjuvant fulvestrant treatment.


6. Patients treated within the last 7 days prior to randomization with:


- Food or drugs that are known to be CYP3A4 inhibitors


- Drugs that are known to be CYP3A4 inducers


- Drugs that are known to prolong the QT interval


7. Patients who received before randomization:


- Any investigational agent within 4 weeks


- Chemotherapy within a period of time that is minor than the cycle length used for
that treatment (e.g. less 3 weeks for fluorouracil, doxorubicine, epirubicin or
less than 1 week for weekly chemotherapy)


- Previous endocrine therapy is permitted without any window


- Radiotherapy within 2 weeks (all acute toxic effects must be resolved to NCI
CTCAE version 4.0 grade minor 1, except toxicities not considered a safety risk
for the patient at investigator´s discretion) but patients who received prior
radiotherapy to less than 25 per cent of bone marrow are not eligible independent
of when it was received


- Major surgery or other anti-cancer therapy not previously specified within 4
weeks, (all acute toxic effects must be resolved to NCI CTCAE version 4.0 grade
minor 1, except toxicities not considered a safety risk for the patient at
investigator´s discretion)


8. Diagnosis of any other malignancy within 3 years prior to randomization, except for
adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of
the cervix.


9. QTc major 480msec, family or personal history of long or short QT syndrome, Brugada
syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP).


10. Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging
drug (eg, hypocalcemia, hypokalemia, hypomagnesemia).


11. Any of the following within 6 months of randomization: myocardial infarction,
severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 4.0 Grade
major or equal to 2, atrial fibrillation of any grade, coronary/peripheral artery
bypass graft, symptomatic congestive heart failure, cerebrovascular accident including
transient ischemic attack, or symptomatic pulmonary embolism.


12. Difficulties to swallow tablets, malabsorption syndrome disease significantly
affecting gastrointestinal function, resection of the stomach or small bowel, or
active inflammatory bowel disease or chronic diarrhea.


13. Known hypersensitivity to exemestane, palbociclib, capecitabine, fulvestrant or any of
their excipients.


14. Any of the following contraindications for chemotherapy with capecitabine:


- Known deficiency or family history of deficiency of dihydropyrimidine
dehydrogenase.


- Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or
chemically related analogues, such as brivudine.


15. Only for patients in Cohort 2 any of the following contraindications for treatment
with fulvestrant:


- Bleeding diathesis (i.e., disseminated intravascular coagulation [DIC], clotting
factor deficiency) or long-term anticoagulant therapy (other than antiplatelet therapy
and low dose warfarin) provided that the International Normalised Ratio (INR) is less
than 1.6.


16. Known human immunodeficiency virus infection.


17. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the patient
inappropriate for entry into this study.


18. Recent or active suicidal ideation or behavior

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Advanced Information
Descriptive Information
Brief Title  ICMJE Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors
Official Title  ICMJE Phase III Study of Palbociclib in Combination With Exemestane or Fulvestrant vs. Chemotherapy (Capecitabine) in Hormonal Receptor Positive/HER2 Negative Metastatic Breast Cancer Patients With Resistance to Aromatase Inhibitors
Brief Summary This is an international (4 countries) randomized phase III study with 2 cohorts, patients will be randomized 1:1 to endocrine therapy (cohort 1: exemestane 25 mg daily, cohort 2: fulvestrant 500mg days 1 and 15 cycle 1 and then day 1 every 4 weeks) plus palbociclib (125 mg daily x3 weeks every 4 weeks) vs. capecitabine (1,250 mg/m2 twice daily x2 weeks every 3 weeks). Postmenopausal patients with HR+/HER2 MBC are eligible if resistant to previous nonsteroidal aromatase inhibitors (NSAI) (letrozole or anastrozole) in cohort 1 or previous aromatase inhibitors (AI) (letrozole, anastrozole or exemestane) in cohort 2 defined as: recurrence while on or within 12 months after the end of adjuvant treatment with NSAI/AI or progression while on or within 1 month after the end of treatment with NSAI/AI for MBC. Previous chemotherapy is permitted either in the (neo)adjuvant setting and/or as first line for MBC. Patients must have measurable disease according to RECIST 1.1 or bone lesions, lytic or mixed, in the absence of measurable disease.
Detailed Description

296 patients have been randomized 1:1 between the experimental arm (Arm A: approximately 125 patients treated with palbociclib plus exemestane) and the control arm (Arm B: approximately 125 patients treated with capecitabine) before the approval of this protocol version (Cohort 1).

Approximately 300 patients will be randomized 1:1 between the experimental arm (Arm A: approximately 150 patients treated with palbociclib plus fulvestrant) and the control arm (Arm B: approximately 150 patients treated with capecitabine) from the approval of this protocol version (Cohort 2).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE
  • Drug: Palbociclib
    Other Name: Ibrance
  • Drug: Capecitabine
    Other Name: Xeloda
  • Drug: Exemestane
    Other Name: aromasil
  • Drug: Fulvestrant
    Other Name: faslodex
Study Arms  ICMJE
  • Experimental: Palbociclib plus Exemestane or Fulvestrant

    Palbociclib 125 mg orally once daily on Day 1 to Day 21 followed by 7 days off treatment on every 28 days cycles in combination with

    • Cohort 1: Exemestane 25 mg orally once daily.
    • Cohort 2: Fulvestrant 500 mg on Days 1 and 15 of Cycle 1, and Day 1 of each subsequent 28 days Cycle.
    Interventions:
    • Drug: Palbociclib
    • Drug: Exemestane
    • Drug: Fulvestrant
  • Active Comparator: Capecitabine
    Capecitabine, 1,250 mg/m2 twice daily for 2 weeks followed by a 1 week rest period, given as 3 weeks cycles. Capecitabine must be administered at a dose of 1,000 mg/m2 twice daily for 2 weeks followed by a 1 week of rest period, given as 3 weeks cycles, in patients over 70 years of age.
    Intervention: Drug: Capecitabine
Publications * Not Provided

*   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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 4, 2018)
596
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2014)
348
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date January 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The patient has signed the informed consent document.
  2. a) Patients in cohort 1: Females with histologically confirmed MBC whose disease is resistant to previous non-steroidal aromatase inhibitors (letrozole or anastrozole) b) Patients in cohort 2: Females with histologically confirmed MBC whose disease was resistant to previous aromatase inhibitors (exemestane, letrozole or anastrozole).

    Resistance is defined as: Recurrence while on or within 12 months after the end of adjuvant treatment with NSAI/AI or Progression while on or within 1 month after the end of treatment with NSAI/AI for advanced disease.

  3. Previous chemotherapy is permitted either in the (neo) adjuvant setting and/or first line therapy for MBC (chemotherapy administered as "second adjuvant therapy" for locoregional recurrence should be considered as first line chemotherapy for MBC).
  4. It is not mandatory to have exemestane, letrozole or anastrozole as the most recent treatment before randomization but recurrence or progression of breast cancer while receiving (or immediately after the enf of) the most recent systemic therapy has to be documented before randomization.
  5. Hormonal receptor positive (HR+) breast cancer based on local laboratory determination. HR+ defined as major or equal to 1 percent positive cells by Immunohistochemistry (IHC) for ER and/or Progesterone Receptor (PgR).
  6. Documented HER2 negative breast cancer based on local laboratory determination on most recent tumor biopsy. HER2 negative tumor is determined as IHC score 0 or 1+ or negative by ISH (FISH/Chromogenic In Situ Hybridization (CISH)/SISH) defined as a HER2/CEP17 ratio minor to 2 or for single probe assessment a HER2 copy number minor to 4.
  7. Measurable disease or at least one bone lesion, lytic or mixed (lytic+blastic), which has not been previously irradiated and is assessable by CT/MRI in the absence of measurable disease according to RECIST 1.1 criteria.
  8. Patient is at least 18 years of age.
  9. Eastern Cooperative Oncology Group (ECOG) Performance Status minor or equal to 1.
  10. Life expectancy major or equal to 12 weeks.
  11. Adequate organ and bone marrow function.
  12. Postmenopausal women defined as women with:

    Prior bilateral surgical oophorectomy, or Age > 60 years, or Age < 60 years and medically confirmed post-menopausal status defined as spontaneous cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause or follicle-stimulating hormone (FSH) and estradiol blood levels in their respective postmenopausal ranges

  13. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 Grade minor or equal to 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator´s discretion).
  14. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

  1. Have received more than 1 prior chemotherapy regimen for MBC. (NOTE: Chemotherapy administered as "second adjuvant therapy" for locoregional recurrence should be considered one prior chemotherapy for MBC).Other previous anticancer endocrine treatments for advanced disease are allowed.
  2. Patients with advanced, symptomatic, visceral spread that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions (pleural, pericardial, peritoneal), pulmonary lymphangitis and over 50% liver involvement).
  3. Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy,) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
  4. Prior treatment with any CDK4/6, mTOR or PI3K inhibitor (any agent whose mechanism of action is to inhibit the PI3 kinase-mTOR pathway) or capecitabine.
  5. a) Patients included in cohort 1: Prior treatment with exemestane in the metastatic setting. If the patient has received exemestane in the adjuvant setting and developed MBC, she will be eligible for the study provided:

    • She has received letrozole/anastrozole as first-line MBC and progressed.
    • At least 1 year has elapsed since the end of adjuvant exemestane treatment. b) Patients included in Cohort 2: Prior treatment with fulvestrant in the metastatic setting. If the patient has received fulvestrant in the adjuvant setting and developed MBC, she will be eligible for the study provided:
    • She has received letrozole/anastrozole as first-line MBC and progressed.
    • At least 1 year has elapsed since the end of adjuvant fulvestrant treatment.
  6. Patients treated within the last 7 days prior to randomization with:

    • Food or drugs that are known to be CYP3A4 inhibitors
    • Drugs that are known to be CYP3A4 inducers
    • Drugs that are known to prolong the QT interval
  7. Patients who received before randomization:

    • Any investigational agent within 4 weeks
    • Chemotherapy within a period of time that is minor than the cycle length used for that treatment (e.g. less 3 weeks for fluorouracil, doxorubicine, epirubicin or less than 1 week for weekly chemotherapy)
    • Previous endocrine therapy is permitted without any window
    • Radiotherapy within 2 weeks (all acute toxic effects must be resolved to NCI CTCAE version 4.0 grade minor 1, except toxicities not considered a safety risk for the patient at investigator´s discretion) but patients who received prior radiotherapy to less than 25 per cent of bone marrow are not eligible independent of when it was received
    • Major surgery or other anti-cancer therapy not previously specified within 4 weeks, (all acute toxic effects must be resolved to NCI CTCAE version 4.0 grade minor 1, except toxicities not considered a safety risk for the patient at investigator´s discretion)
  8. Diagnosis of any other malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
  9. QTc major 480msec, family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP).
  10. Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging drug (eg, hypocalcemia, hypokalemia, hypomagnesemia).
  11. Any of the following within 6 months of randomization: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 4.0 Grade major or equal to 2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
  12. Difficulties to swallow tablets, malabsorption syndrome disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, or active inflammatory bowel disease or chronic diarrhea.
  13. Known hypersensitivity to exemestane, palbociclib, capecitabine, fulvestrant or any of their excipients.
  14. Any of the following contraindications for chemotherapy with capecitabine:

    • Known deficiency or family history of deficiency of dihydropyrimidine dehydrogenase.
    • Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine.
  15. Only for patients in Cohort 2 any of the following contraindications for treatment with fulvestrant:

    - Bleeding diathesis (i.e., disseminated intravascular coagulation [DIC], clotting factor deficiency) or long-term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin) provided that the International Normalised Ratio (INR) is less than 1.6.

  16. Known human immunodeficiency virus infection.
  17. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  18. Recent or active suicidal ideation or behavior
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Hungary,   Israel,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02028507
Other Study ID Numbers  ICMJE GEICAM/2013-02
2013-003170-27 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spanish Breast Cancer Research Group
Study Sponsor  ICMJE Spanish Breast Cancer Research Group
Collaborators  ICMJE
  • Pfizer
  • AstraZeneca
Investigators  ICMJE
Study Director:Study DirectorIiSGM, Universidad Complutense de Madrid, Madrid, Spain.
PRS Account Spanish Breast Cancer Research Group
Verification Date August 2020

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