Palbociclib Plus Letrozole in Hormone Receptor Positive Residual Disease After Neoadjuvant Chemotherapy

NCT04130152

Last updated date
Study Location
Hospital General de Catalunya
Barcelona, , , Spain
Contact
+34638784908

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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. Written and signed informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.

2. Female patients age ≥ 18 years.

3. ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 to 1.

4. Histologically confirmed non-metastatic primary HR-positive/HER2 negative breast cancer with all the following characteristics:

- Breast cancer eligible for surgery.

- ER-positive and/or PgR-positive and HER2-negative tumor by the most recent ASCO/CAP guidelines, before neoadjuvant treatment locally assessed.

- Ki67% ≥ 5% after neoadjuvant chemotherapy locally assessed (Dowsett M et al JNCI 2011).

- A lesion that could be confirmed by ultrasound (US) after neoadjuvant chemotherapy.

5. Completed ≥80% total dose of an anthracycline/taxane-based neoadjuvant regimen planned. The allowed chemotherapy regimens will be AC (cyclophosphamide, doxorubicin) or EC (epirubicin, cyclophosphamide) 4 cycles followed by weekly paclitaxel x 12 or AC or EC 4 cycles followed by docetaxel 4 cycles. It would be acceptable to change the administration sequence to paclitaxel followed by AC/EC. AC can be given either a standard dose or in a dose-dense schedule. Paclitaxel could be administered as a solvent-based or Nanoparticle albumin-bound (Nab) formulation.

6. Availability of a recent formalin-fixed paraffin-embedded (FFPE) tumor sample before NAC and a research tumor biopsy after NAC. Minimal sample requirements are to have at least 2 tumor cylinders with a minimal tissue surface of 10 mm2 tissue, containing at least 10% tumor cells and having enough tissue to do at least 2 cuts of 10 μm each.

7. Adequate organ function determined within 28 days prior to enrollment, defined as follows:

- Hematological

- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

- Platelet count ≥ 100 x 109/L

- Hemoglobin ≥ 9 g/dL (red blood cell transfusion and/or erythropoietin allowed)

- Renal

• Serum creatinine ≤ 1.5 x upper limit of normal (ULN), or 24-hour creatinine clearance ≥ 60 mL/min for a subject with creatinine levels >1.5 x ULN. (Note: Creatinine clearance does not need to be determined if the baseline serum creatinine is within normal limits. Creatinine clearance should be calculated per institutional standard).

- Hepatic

- Serum bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for a subject with total bilirubin level > 1.5 x ULN

- Aspartate aminotransferase (AST) ≤ 2.5 x ULN

- Alanine aminotransferase (ALT) ≤ 2.5 x ULN Coagulation International normalization ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN

8. Serum or urine pregnancy test must be negative within 7 days prior enrollment in women of childbearing potential. If the urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before randomization, as determined by local practice, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. Women of childbearing potential enrolled to the treatment must use adequate contraception for the duration of protocol treatment.

9. Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

10. Resolution of all acute toxic effects of prior anti-cancer therapy to NCI CTCAE version 5.0 Grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator´s discretion).

11. Pre/peri-menopausal and post-menopausal women are allowed; menopausal status is relevant for the requirement of goserelin or triptorelin to be used concomitantly with palbociclib plus letrozole. Post-menopausal status is defined either by:

- Prior bilateral oophorectomy or

- Age ≥60 or

- Age < 60 and amenorrhea for ≥ 12 months prior to the start of neoadjuvant chemotherapy and FSH and estradiol in the post-menopausal range per local standards prior to the start of neoadjuvant chemotherapy.

For patients who do not meet the one of the previous parameters, therapy-induced amenorrhea (goserelin or triptorelin), it must have been started more 14 days before the start of palbociclib plus letrozole treatment.

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


1. Non-operable, locally advanced breast cancer (inoperable stage III) after NAC.


2. Bilateral or metastatic invasive breast cancer at the time of the diagnosis.


3. Known severe hypersensitivity reactions to compounds similar to palbociclib or to
excipients or to endocrine treatments.


4. History of any previous treatment using Aromatase inhibitors (AI) o selective estrogen
receptor modulator (SERMs) in the past 5 years.


5. Prior therapy with palbociclib or any cyclin-dependent kinase (CDK) inhibitor.


6. Concurrent treatment with other experimental drugs. Participation in another clinical
trial with any investigational not marketed drug within 30 days prior to enrollment.


7. Patients receiving any medications or substances that are strong inhibitors or
inducers of CYP3A isoenzymes within 7 days of randomization.


8. Any surgery (not including minor procedures such as primary tumor core biopsy, fine
needle aspiration) within 4 weeks of start of study treatment; or not fully recovered
from any side effects of previous procedures.


9. Sentinel lymph node biopsy is not allowed before NAC.


10. Diagnosis of any previous malignancy within the last 3 years, except for adequately
treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical
carcinoma


11. Malabsorption syndrome or other condition that would interfere with enteric
absorption.


12. Clinically significant history of liver disease, including viral or other hepatitis,
current alcohol abuse, or cirrhosis.


13. Uncontrolled electrolyte disorders (eg, hypocalcemia, hypokalemia, hypomagnesemia).


14. Any of the following within 6 months of enrollment: myocardial infarction,
severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 5.0 Grade
≥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.


15. Corrected QT interval (QTc) greater than 480 msec or a family or personal history of
long or short QT syndrome, Brugada syndrome or know history of QTc prolongation, or
Torsade de Pointes (TdP).


16. Uncontrolled current illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, diabetes, or psychiatric illness/social situations that would limit
compliance with study requirements. Ability to comply with study requirements is to be
assessed by each investigator at the time of screening for study participation.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Palbociclib Plus Letrozole in Hormone Receptor Positive Residual Disease After Neoadjuvant Chemotherapy
Official Title  ICMJE Palbociclib in Combination With Letrozole in Patients With Hormone Receptor (HR) Positive/Human Epidermal Growth Factor Receptor 2 (HER2) Negative Residual Disease After Standard Neoadjuvant Chemotherapy (PROMETEO II)
Brief Summary PROMETEO II is a single-arm window of opportunity trial to evaluate biologic and anti-proliferative effects of palbociclib and letrozole in HR+/HER2-negative operable breast cancer (BC) patients with residual disease after neoadjuvant chemotherapy (NAC) and help to identify biomarkers for better patient selection.
Detailed Description

This is a single-arm window of opportunity trial to evaluate biologic and anti-proliferative effects of palbociclib and letrozole in HR+/HER2-negative operable BC patients with residual disease after NAC and help to identify biomarkers for better patient selection.

The primary endpoint will be the Complete Cell Cycle Arrest (CCCA) determined by Ki67<2.7%, centrally assessed at surgery after 4 weeks of palbociclib and letrozole.

Tumor measurement will be performed by ultrasound (US) for disease evaluation and confirmation of residual disease will be performed at screening at the end of NAC. The biopsy after chemotherapy will only be done after confirmation of residual disease by US. Ki67% ? 5% after NAC by local determination will be necessary to be included in the study.

Patients will be administered palbociclib at a dose of 125 mg once daily, day 1 to day 21 followed by 7 days off treatment in a 28-day cycle and letrozole: oral, 2.5 mg per day continuously, one cycle of treatment.

After the finalization of the neoadjuvant treatment, patients will undergo surgery. Surgery specimens will be collected for histological examination and biomarker analysis

The end of the study is defined as the date of post-surgery visit and will take place 4 weeks (+/- 7days) after the surgery in order to monitor the patient's safety and collect the surgery information.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Palbociclib
    Palbociclib 125 mg once daily, day 1 to day 21, followed by 7 days off treatment in a 28-day cycle
    Other Name: Ibrance
  • Drug: Letrozole
    Letrozole: oral, 2.5 mg per day continuously. during the 28-day cycle.
Study Arms  ICMJE Experimental: Palbociclib + Letrozole

Palbociclib 125 mg once daily, day 1 to day 21, followed by 7 days off treatment in a 28-day cycle Letrozole: oral, 2.5 mg per day continuously. during the 28-day cycle.

If the patient is pre-menopausal, ovarian suppression with luteinizing hormone-releasing hormone (LHRH) analogues (ie, triptorelin 3.75 mg intra-muscular (IM) or Goserelin 3,6 mg SC) must be initiated at least 2 weeks before palbociclib plus letrozole administration.

Interventions:
  • Drug: Palbociclib
  • Drug: Letrozole
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 15, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Written and signed informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.
  2. Female patients age ? 18 years.
  3. ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 to 1.
  4. Histologically confirmed non-metastatic primary HR-positive/HER2 negative breast cancer with all the following characteristics:

    • Breast cancer eligible for surgery.
    • ER-positive and/or PgR-positive and HER2-negative tumor by the most recent ASCO/CAP guidelines, before neoadjuvant treatment locally assessed.
    • Ki67% ? 5% after neoadjuvant chemotherapy locally assessed (Dowsett M et al JNCI 2011).
    • A lesion that could be confirmed by ultrasound (US) after neoadjuvant chemotherapy.
  5. Completed ?80% total dose of an anthracycline/taxane-based neoadjuvant regimen planned. The allowed chemotherapy regimens will be AC (cyclophosphamide, doxorubicin) or EC (epirubicin, cyclophosphamide) 4 cycles followed by weekly paclitaxel x 12 or AC or EC 4 cycles followed by docetaxel 4 cycles. It would be acceptable to change the administration sequence to paclitaxel followed by AC/EC. AC can be given either a standard dose or in a dose-dense schedule. Paclitaxel could be administered as a solvent-based or Nanoparticle albumin-bound (Nab) formulation.
  6. Availability of a recent formalin-fixed paraffin-embedded (FFPE) tumor sample before NAC and a research tumor biopsy after NAC. Minimal sample requirements are to have at least 2 tumor cylinders with a minimal tissue surface of 10 mm2 tissue, containing at least 10% tumor cells and having enough tissue to do at least 2 cuts of 10 ?m each.
  7. Adequate organ function determined within 28 days prior to enrollment, defined as follows:

    • Hematological

      • Absolute neutrophil count (ANC) ? 1.5 x 109/L
      • Platelet count ? 100 x 109/L
      • Hemoglobin ? 9 g/dL (red blood cell transfusion and/or erythropoietin allowed)
    • Renal

      ? Serum creatinine ? 1.5 x upper limit of normal (ULN), or 24-hour creatinine clearance ? 60 mL/min for a subject with creatinine levels >1.5 x ULN. (Note: Creatinine clearance does not need to be determined if the baseline serum creatinine is within normal limits. Creatinine clearance should be calculated per institutional standard).

    • Hepatic

      • Serum bilirubin ? 1.5 x ULN OR direct bilirubin ? ULN for a subject with total bilirubin level > 1.5 x ULN
      • Aspartate aminotransferase (AST) ? 2.5 x ULN
      • Alanine aminotransferase (ALT) ? 2.5 x ULN Coagulation International normalization ratio (INR) or prothrombin time (PT) ? 1.5 x ULN
  8. Serum or urine pregnancy test must be negative within 7 days prior enrollment in women of childbearing potential. If the urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before randomization, as determined by local practice, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. Women of childbearing potential enrolled to the treatment must use adequate contraception for the duration of protocol treatment.
  9. Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
  10. Resolution of all acute toxic effects of prior anti-cancer therapy to NCI CTCAE version 5.0 Grade ? 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator´s discretion).
  11. Pre/peri-menopausal and post-menopausal women are allowed; menopausal status is relevant for the requirement of goserelin or triptorelin to be used concomitantly with palbociclib plus letrozole. Post-menopausal status is defined either by:

    • Prior bilateral oophorectomy or
    • Age ?60 or
    • Age < 60 and amenorrhea for ? 12 months prior to the start of neoadjuvant chemotherapy and FSH and estradiol in the post-menopausal range per local standards prior to the start of neoadjuvant chemotherapy.

For patients who do not meet the one of the previous parameters, therapy-induced amenorrhea (goserelin or triptorelin), it must have been started more 14 days before the start of palbociclib plus letrozole treatment.

Exclusion Criteria:

  1. Non-operable, locally advanced breast cancer (inoperable stage III) after NAC.
  2. Bilateral or metastatic invasive breast cancer at the time of the diagnosis.
  3. Known severe hypersensitivity reactions to compounds similar to palbociclib or to excipients or to endocrine treatments.
  4. History of any previous treatment using Aromatase inhibitors (AI) o selective estrogen receptor modulator (SERMs) in the past 5 years.
  5. Prior therapy with palbociclib or any cyclin-dependent kinase (CDK) inhibitor.
  6. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to enrollment.
  7. Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization.
  8. Any surgery (not including minor procedures such as primary tumor core biopsy, fine needle aspiration) within 4 weeks of start of study treatment; or not fully recovered from any side effects of previous procedures.
  9. Sentinel lymph node biopsy is not allowed before NAC.
  10. Diagnosis of any previous malignancy within the last 3 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma
  11. Malabsorption syndrome or other condition that would interfere with enteric absorption.
  12. Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
  13. Uncontrolled electrolyte disorders (eg, hypocalcemia, hypokalemia, hypomagnesemia).
  14. Any of the following within 6 months of enrollment: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 5.0 Grade ?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.
  15. Corrected QT interval (QTc) greater than 480 msec or a family or personal history of long or short QT syndrome, Brugada syndrome or know history of QTc prolongation, or Torsade de Pointes (TdP).
  16. Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social situations that would limit compliance with study requirements. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation.
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: Pamela Celiz, MD, PhD+34638784908[email protected]
Contact: Amparo Buenestado, PhD[email protected]
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04130152
Other Study ID Numbers  ICMJE SOLTI-1710
2019-001275-36 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party SOLTI Breast Cancer Research Group
Study Sponsor  ICMJE SOLTI Breast Cancer Research Group
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account SOLTI Breast Cancer Research Group
Verification Date July 2020

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