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Trial record 49 of 99 for:    FEC

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 (NeoPAL)

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ClinicalTrials.gov Identifier: NCT02400567
Recruitment Status : Active, not recruiting
First Posted : March 27, 2015
Last Update Posted : September 7, 2018
Sponsor:
Collaborators:
Pfizer
NanoString Technologies, Inc.
Information provided by (Responsible Party):
UNICANCER

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.

Condition or disease Intervention/treatment Phase
Neoadjuvant Operable Breast Cancer Drug: Fluorouracile Drug: Epirubicin Drug: Cyclophosphamide Drug: Letrozole Drug: Palbociclib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 2015
Actual Primary Completion Date : January 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Chemotherapy
3 cycles of FEC 100 followed by 3 cycles of Docetaxel Drugs: Fluorouracile, Epirubicine, Cyclophosphamide, Docetaxel
Drug: Fluorouracile
Drug: Epirubicin
Drug: Cyclophosphamide
Experimental: Letrozole Palbociclib
Drugs: letrozole + palbociclib combination
Drug: Letrozole
Drug: Palbociclib



Primary Outcome Measures :
  1. Evaluation of the number of patients with a Residual Cancer Burden (RCB) 0-I index as a measure of efficacy [ Time Frame: 21 weeks ]
    Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. 6 variables are included in a calculation formula.


Secondary Outcome Measures :
  1. Evaluation of the clinical response in each treatment arm as defined by clinical and ultrasound examination. [ Time Frame: 21 weeks ]
  2. Determination of the number and type of Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 21 weeks ]
    The toxicity will be evaluated according to the scale CTC-AE version 4.0

  3. Correlation of the PAM50 risk of recurrence (ROR) score to its ability to predict RCB as defined in outcome 1 [ Time Frame: 21 weeks ]
  4. Calculation of the rates of breast conservation therapy in the two arms with regard to the initially planned surgery. [ Time Frame: 21 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400567


Locations
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France
Institut Curie
Paris, France
Gustave Roussy
Villejuif, France
Sponsors and Collaborators
UNICANCER
Pfizer
NanoString Technologies, Inc.
Investigators
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Principal Investigator: Paul Cottu, MD Institut Curie Paris
Principal Investigator: Suzette Delaloge, MD Gustave roussy, Villejuif

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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT02400567     History of Changes
Other Study ID Numbers: NeoPal - UC-0140/1404
2014-002560-33 ( EudraCT Number )
CARMINA04 ( Other Identifier: UNICANCER )
NEOPAL ( Other Identifier: UNICANCER )
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

Keywords provided by UNICANCER:
Luminal
Post menopausal
Breast conservation
Neoadjuvant

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Letrozole
Epirubicin
Palbociclib
Phenobarbital
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Protein Kinase Inhibitors
Anticonvulsants