Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women

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NCT02400567

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Study Location
Institut Curie
Paris, , , France
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoadjuvant Operable 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. Aged ≥ 18 years, Post-menopausal women

2. Newly diagnosed and operable unilateral invasive breast cancer, not candidate or uncertain for breast conservation - Note: Multicentric/multifocal tumors are allowed provided a maximum of 3 lesions are present, and all share the same characteristics: ER Allred 4, Her2- (PAM50 will be performed in the largest lesion)

3. Stage II-IIIA

4. Assessment of nodal status available (Ultrasound guided FNA or biopsy if necessary)

5. Non metastatic, M0

6. ER-positive by IHC (Allred Score≥4)

7. HER2-negative by IHC (score 0 or 1+) and/or Fish/Cish

8. Either Luminal A AND proven nodal involvement (cytology or histology), or Luminal B through PAM50 ROR (Prosigna™) centralized evaluation

9. ECOG 0-1

10. No prior systemic therapy for the present tumor

11. Adequate renal, hepatic, and hematopoietic functions as defined by the following criteria:

- Absolute Neutrophil Count (ANC) ≥1,500/mm3 or ≥1.5 x 109/L

- Platelets ≥100,000/mm3 or ≥100 x 109/L

- Hemoglobin ≥9 g/dL

- Serum Aspartate Transaminase (AST) and serum Alanine Aminotransferase Transaminase (ALT) ≤2.5 x upper limit of normal (ULN)

- Alkaline phosphatase ≤2.5 x ULN

- Total serum bilirubin ≤1 x ULN

- Serum creatinine ≤1.5 x ULN or estimated creatinine clearance ≥ 60 mL/min as calculated using the method standard for the institution

12. Adequate cardiac functions, including:

- 12 Lead electrocardiogram (ECG) with normal tracing or non clinically significant changes that do not require medical intervention.

- QTc interval ≤480 msec

- No history of Torsades de Pointes or other symptomatic QTc abnormality.

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

14. Signed informed consent and health insurance coverage

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


1. Non operable, bilateral, T4 or metastatic breast cancer


2. Limited T2 breast cancer immediately accessible to conservative surgery


3. Previous homolateral breast cancer (including in situ carcinoma), and/or contralateral
breast cancer except if treated by surgery +/- radiation therapy alone without any
systemic treatment


4. Previous hormone replacement therapy (HRT) stopped less than 2 weeks before beginning
of treatment


5. Previous use of SERMs such as raloxifene


6. Any surgery (not including minor procedures such as lymph node biopsy, 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.


7. Diagnosis of any previous malignancy within the last 5 years, except for adequately
treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical
carcinoma


8. History of any previous anti-cancer chemotherapy and any previous treatment using AI


9. Concurrent administration of herbal preparations as complementary medicine.


10. Any clinically significant gastrointestinal abnormalities, which may impair intake,
transit or absorption of the study drugs, such as the inability to take oral
medication in tablet form and malabsorption syndrome


11. Patient with any psychological, familial, social or geographical condition which could
potentially hamper compliance with the study protocol and follow-up schedule; those
conditions should be discussed with the patient before registration in the trial.

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Neoadjuvant Operable Breast CancerEfficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women
NCT02400567
  1. Paris,
  2. Villejuif,
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women
Official Title  ICMJE Open-label, Randomized, Multicenter, International, Parallel Exploratory Phase II Study, Comparing 3 FEC-3 Docetaxel Chemotherapy to Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women
Brief Summary The investigators propose in the present study an innovative approach, combining the most recent therapeutic opportunities in high risk ER+ breast cancer with the most recent and innovative diagnostic approaches such as the PAM50 signature and the RCB tumor response evaluation method. In line with the most recent recommendations on targeted anticancer therapies, the investigators have designed a parallel phase II randomized trial with early stopping rules 26, which will able in the meantime to build a unique prospective collection of tumor tissue, pre- and post-treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoadjuvant Operable Breast Cancer
Intervention  ICMJE
  • Drug: Fluorouracile
  • Drug: Epirubicin
  • Drug: Cyclophosphamide
  • Drug: Letrozole
  • Drug: Palbociclib
Study Arms  ICMJE
  • Active Comparator: Chemotherapy
    3 cycles of FEC 100 followed by 3 cycles of Docetaxel Drugs: Fluorouracile, Epirubicine, Cyclophosphamide, Docetaxel
    Interventions:
    • Drug: Fluorouracile
    • Drug: Epirubicin
    • Drug: Cyclophosphamide
  • Experimental: Letrozole Palbociclib
    Drugs: letrozole + palbociclib combination
    Interventions:
    • Drug: Letrozole
    • Drug: Palbociclib
Publications * Cottu P, D'Hondt V, Dureau S, Lerebours F, Desmoulins I, Heudel PE, Duhoux FP, Levy C, Mouret-Reynier MA, Dalenc F, Frenel JS, Jouannaud C, Venat-Bouvet L, Nguyen S, Ferrero JM, Canon JL, Grenier J, Callens C, Gentien D, Lemonnier J, Vincent-Salomon A, Delaloge S. Letrozole and palbociclib versus chemotherapy as neoadjuvant therapy of high-risk luminal breast cancer. Ann Oncol. 2018 Dec 1;29(12):2334-2340. doi: 10.1093/annonc/mdy448.

*   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
Actual Enrollment  ICMJE
 (submitted: May 3, 2017)		125
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2015)		132
Estimated Study Completion Date  ICMJE September 2020
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Aged ? 18 years, Post-menopausal women
  2. Newly diagnosed and operable unilateral invasive breast cancer, not candidate or uncertain for breast conservation - Note: Multicentric/multifocal tumors are allowed provided a maximum of 3 lesions are present, and all share the same characteristics: ER Allred 4, Her2- (PAM50 will be performed in the largest lesion)
  3. Stage II-IIIA
  4. Assessment of nodal status available (Ultrasound guided FNA or biopsy if necessary)
  5. Non metastatic, M0
  6. ER-positive by IHC (Allred Score?4)
  7. HER2-negative by IHC (score 0 or 1+) and/or Fish/Cish
  8. Either Luminal A AND proven nodal involvement (cytology or histology), or Luminal B through PAM50 ROR (Prosigna?) centralized evaluation
  9. ECOG 0-1
  10. No prior systemic therapy for the present tumor

  11. Adequate renal, hepatic, and hematopoietic functions as defined by the following criteria:

    • Absolute Neutrophil Count (ANC) ?1,500/mm3 or ?1.5 x 109/L
    • Platelets ?100,000/mm3 or ?100 x 109/L
    • Hemoglobin ?9 g/dL
    • Serum Aspartate Transaminase (AST) and serum Alanine Aminotransferase Transaminase (ALT) ?2.5 x upper limit of normal (ULN)
    • Alkaline phosphatase ?2.5 x ULN
    • Total serum bilirubin ?1 x ULN
    • Serum creatinine ?1.5 x ULN or estimated creatinine clearance ? 60 mL/min as calculated using the method standard for the institution

  12. Adequate cardiac functions, including:

    • 12 Lead electrocardiogram (ECG) with normal tracing or non clinically significant changes that do not require medical intervention.
    • QTc interval ?480 msec
    • No history of Torsades de Pointes or other symptomatic QTc abnormality.
  13. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
  14. Signed informed consent and health insurance coverage

Exclusion Criteria:

  1. Non operable, bilateral, T4 or metastatic breast cancer
  2. Limited T2 breast cancer immediately accessible to conservative surgery
  3. Previous homolateral breast cancer (including in situ carcinoma), and/or contralateral breast cancer except if treated by surgery +/- radiation therapy alone without any systemic treatment
  4. Previous hormone replacement therapy (HRT) stopped less than 2 weeks before beginning of treatment
  5. Previous use of SERMs such as raloxifene
  6. Any surgery (not including minor procedures such as lymph node biopsy, 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.
  7. Diagnosis of any previous malignancy within the last 5 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma
  8. History of any previous anti-cancer chemotherapy and any previous treatment using AI
  9. Concurrent administration of herbal preparations as complementary medicine.
  10. Any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drugs, such as the inability to take oral medication in tablet form and malabsorption syndrome
  11. Patient with any psychological, familial, social or geographical condition which could potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
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 France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02400567
Other Study ID Numbers  ICMJE NeoPal - UC-0140/1404
2014-002560-33 ( EudraCT Number )
CARMINA04 ( Other Identifier: UNICANCER )
NEOPAL ( Other Identifier: UNICANCER )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
Supporting Materials:Study Protocol
Supporting Materials:Statistical Analysis Plan (SAP)
Time Frame:Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.
Access Criteria:The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.
Responsible Party UNICANCER
Study Sponsor  ICMJE UNICANCER
Collaborators  ICMJE
  • Pfizer
  • NanoString Technologies, Inc.
Investigators  ICMJE
Principal Investigator:Paul Cottu, MDInstitut Curie Paris
Principal Investigator:Suzette Delaloge, MDGustave roussy, Villejuif
PRS Account UNICANCER
Verification Date October 2019

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