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
NCT02400567
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FOR MORE INFORMATION
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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
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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Descriptive Information | |||||||||||||
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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 |
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Study Arms ICMJE |
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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 | 125 | ||||||||||||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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Responsible Party | UNICANCER | ||||||||||||
Study Sponsor ICMJE | UNICANCER | ||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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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 |