Status:
COMPLETED
Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant
Lead Sponsor:
International Cancer Research Group, United Arab Emirates
Collaborating Sponsors:
AstraZeneca
Pfizer
Conditions:
Breast Neoplasm Female
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This is a multicenter, international, double-blind randomized Phase III study to evaluate the pathological complete response (pCR) according to Chevalier classification between Fulvestrant® and the co...
Detailed Description
This is a multicenter, international, double-blind, randomized study. Eligible patients based on inclusion/exclusion criteria will be assessed using OncotypeDX molecular test. Patients with low/inter...
Eligibility Criteria
Inclusion
- Written informed consent prior to beginning specific protocol procedures including expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to the local regulatory requirements.
- Age \>18.
- Postmenopausal women or pre-menopausal (with medical or surgical oophorectomy)
- Performance status \< 2 (according to WHO criteria).
- Histologically confirmed non-metastatic breast cancer (Luminal A or B)
- HR (hormone receptor ) positive (Estrogen or Progesterone)\> 1%.
- Her-2 negative (score 0 or 1 by immunochemistry), FISH (fluorescence in situ hybridization) negative if IHC (immuno-histochemistry) score 2).
- Clinical stage II and IIIa.
- No previous breast cancer treatment by surgery, radiotherapy, hormone therapy or chemotherapy.
- Measurable or evaluable disease.
- Hematology:
- Neutrophil count ≥ 1.5 G/L.
- Platelet count ≥ 100 G/L.
- Leucocyte count \> 3.0 G/L.
- Hb\> 9g/dl.
- Hepatic function:
- Total bilirubin ≤ 1.5 time the Upper Normal Limit (UNL).
- ASAT (alanine aminotransferase aspartate transaminase ) ≤ 2.5xUNL.
- ALAT (alanine aminotransferase) ≤ 2.5xUNL.
- Alkaline phosphatase ≤ 2.5 time the upper normal limit (UNL).
- Renal function:
- Serum creatinine ≤1.5xUNL (and if Serum creatinine \>1.5xUNL, creatinine clearance ≥50 mL/min).
- Creatinine clearance ≥40 mL/min in case of MRI.
- Metabolic function:
- Serum magnesium ≥ lower limit of normal.
- Serum calcium ≥ lower limit of normal.
- No progressive heart disease and no anthracycline contraindication (normal LVEF ( left ventricular ejection fraction) according to the institution guidelines).
- Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment.
Exclusion
- Male patients.
- Her-2 positive tumors or unknown HR/Her-2 status.
- Pregnancy or breast-feeding, or plan to become pregnant within 6 months post treatment.
- No willingness to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months post treatment.
- Any form of breast cancer other than those described in the inclusion criteria, particularly inflammatory and/or overlooked forms (stages IIIb or IV).
- Non-measurable tumour.
- Bilateral breast cancer.
- Previous treatment for breast cancer including surgery for their disease or have had primary axillary dissection, radiotherapy and systemic therapy.
- Patient with history of other cancer, except in situ cervical cancer or baso-cellular skin cancer, considered cured.
- Patient has another disease, which is deemed incompatible with the inclusion in the protocol.
- Heart, kidney, medullary, respiratory or liver failure. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment in the study.
- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease at baseline
- Acute urinary infection, ongoing hemorrhagic cystitis.
- Uncontrolled diabetes.
- Symptomatic or progressive disorder of the central nervous system (CNS) Peripheral neuropathy \> grade 2
- Significant psychiatric abnormalities.
- History of hypersensitivity to studied treatment or excipients
- Known previous or ongoing abuse narcotic drug, other medication or alcohol
- Any investigational agent within 30 days before initiation of study treatment.
- No major surgical procedure within 28 days of initiation of treatment.
- Subject unwilling or unable to comply with study requirement.
Key Trial Info
Start Date :
December 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2021
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT03447132
Start Date
December 20 2017
End Date
July 20 2021
Last Update
March 10 2023
Active Locations (14)
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1
Center Pierre et Marie Curie
Algiers, Algeria
2
Cancer Center - Blida
Blida, Algeria
3
CHU - Oran
Oran, Algeria
4
University of Alexandria
Alexandria, Egypt