Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant
NCT03447132
ABOUT THIS STUDY
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1. 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.
2. Age >18.
3. Postmenopausal women or pre-menopausal (with medical or surgical oophorectomy)
4. Performance status < 2 (according to WHO criteria).
5. 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).
6. Clinical stage II and IIIa.
7. No previous breast cancer treatment by surgery, radiotherapy, hormone therapy or chemotherapy.
8. Measurable or evaluable disease.
9. Hematology:
- Neutrophil count ≥ 1.5 G/L.
- Platelet count ≥ 100 G/L.
- Leucocyte count > 3.0 G/L.
- Hb> 9g/dl.
10. 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).
11. 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.
12. Metabolic function:
- Serum magnesium ≥ lower limit of normal.
- Serum calcium ≥ lower limit of normal.
13. No progressive heart disease and no anthracycline contraindication (normal LVEF ( left ventricular ejection fraction) according to the institution guidelines).
14. 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.
1. Male patients.
2. Her-2 positive tumors or unknown HR/Her-2 status.
3. Pregnancy or breast-feeding, or plan to become pregnant within 6 months post
treatment.
4. No willingness to use highly effective methods of contraception (per institutional
standard) during treatment and for 6 months post treatment.
5. Any form of breast cancer other than those described in the inclusion criteria,
particularly inflammatory and/or overlooked forms (stages IIIb or IV).
6. Non-measurable tumour.
7. Bilateral breast cancer.
8. Previous treatment for breast cancer including surgery for their disease or have had
primary axillary dissection, radiotherapy and systemic therapy.
9. Patient with history of other cancer, except in situ cervical cancer or baso-cellular
skin cancer, considered cured.
10. Patient has another disease, which is deemed incompatible with the inclusion in the
protocol.
11. 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.
12. Uncontrolled diabetes.
13. Symptomatic or progressive disorder of the central nervous system (CNS) Peripheral
neuropathy > grade 2
14. Significant psychiatric abnormalities.
15. History of hypersensitivity to studied treatment or excipients
16. Known previous or ongoing abuse narcotic drug, other medication or alcohol
17. Any investigational agent within 30 days before initiation of study treatment.
18. No major surgical procedure within 28 days of initiation of treatment.
19. Subject unwilling or unable to comply with study requirement.
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Descriptive Information | |||||||||
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Brief Title ICMJE | Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant | ||||||||
Official Title ICMJE | Multicentre, International Neoadjuvant Randomized Double-blind Trial Comparing Fulvestrant® to a Combination of Fulvestrant® and Palbociclib (CDK 4/6 Inhibitor) in Patients With Operable Luminal Breast Cancer Responding to Fulvestrant® | ||||||||
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 combination of Fulvestrant® plus Palbociclib as neoadjuvant therapy of hormone-sensitive patients with operable luminal breast cancer. Eligible patients will be assessed upfront using the OncotypeDX® molecular test (Recurrence Score <31). | ||||||||
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/intermediate risk (Recurrence Score <31) will be treated with the induction neoadjuvant Fulvestrant (500 mg (milligram) intra muscular(i.m) at Day 1, 14 and 28 and then every 4 weeks), plus Goserelin (3.6 mg subcutaneous (s.c) every 4 weeks, only for pre and peri-menopausal patients) for 4 months, followed by clinical and radiological assessment of the disease response. Patients with objective response or stabilization will be randomized and treated for 4 additional months with:
or
Patients with documented progressive disease will be considered at the discretion of the investigator for surgery or neoadjuvant chemotherapy. The preferred chemotherapy protocol will be FEC 100 -Taxotere (5fluorouracil 500mg/m2, Epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2 (FEC) q3 weeks for 3 cycles followed by Docetaxel 100 mg/m2 (T) q 3 weeks for 3 cycles) for a total of 6 cycles with clinical and radiological assessment after each 3 cycles of chemotherapy (CT). Chemotherapy candidates will as well undergo surgery. The expected interval between the cycles will be 21 days, unless the patient has not recovered from toxicity. Specific dose adjustments will be set out in the protocol. Breast and nodal surgery will be performed at completion of therapy (8 months of hormonal therapy for responding patients and 6 additional cycles of CT for non-responders). The type of surgery will be left at the discretion of the investigators. Radiation therapy and adjuvant systemic treatment and endocrine therapy will be as well left at the discretion of the investigators. Patients will be followed every 6 months during 5 years post surgery. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||||
Condition ICMJE | Breast Neoplasm Female | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* 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 | Recruiting | ||||||||
Estimated Enrollment ICMJE | 400 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | September 1, 2023 | ||||||||
Estimated Primary Completion Date | September 1, 2023 (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 |
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Listed Location Countries ICMJE | Algeria, Egypt, Jordan, Lebanon, Morocco, Saudi Arabia, Tunisia, United Arab Emirates | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03447132 | ||||||||
Other Study ID Numbers ICMJE | ICRG1201 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | International Cancer Research Group, United Arab Emirates | ||||||||
Study Sponsor ICMJE | International Cancer Research Group, United Arab Emirates | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | International Cancer Research Group, United Arab Emirates | ||||||||
Verification Date | November 2018 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |