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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer

NCT02296801

Breast Cancer Breast Carcinoma Breast Tumors

COMPLETED PHASE2

Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer

NCT02907918

Breast Cancer Cancer of Breast Breast Carcinoma

TERMINATED PHASE2

Palbociclib + Letrozole Versus Epirubicin + Cyclophosphamide and Sequential Docetaxel as Neoadjuvant Chemotherapy

NCT04137640

Breast Cancer

NOT_YET_RECRUITING PHASE4

Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer

NCT03128619

Estrogen Receptor Positive HER2/Neu Negative Invasive Breast Carcinoma +14 more

TERMINATED PHASE1

Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer

NCT03628066

Breast Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoadjuvant Operable Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Chemotherapy

3 cycles of FEC 100 followed by 3 cycles of Docetaxel Drugs: Fluorouracile, Epirubicine, Cyclophosphamide, Docetaxel

Group Type ACTIVE_COMPARATOR

Fluorouracile

Intervention Type DRUG

Epirubicin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Letrozole Palbociclib

Drugs: letrozole + palbociclib combination

Group Type EXPERIMENTAL

Letrozole

Intervention Type DRUG

Palbociclib

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluorouracile

Intervention Type DRUG

Epirubicin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Letrozole

Intervention Type DRUG

Palbociclib

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No