A Randomized Controlled Study to Evaluate the Efficacy and Safety of Endocrine Therapy Plus Chemotherapy Versus Chemotherapy Alone as the Neoadjuvant Therapy in the Treatment of ER-positive, HER2-negative Breast Cancer (IIa-IIIc)
Overview
- Phase
- Phase 3
- Intervention
- letrozole, leuprorelin, fluorouracil, epirubicin, cyclophosphamide, docetaxel
- Conditions
- Breast Cancer Female
- Sponsor
- Fudan University
- Enrollment
- 249
- Locations
- 1
- Primary Endpoint
- objective response rate (ORR)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This was an open-label, randomized controlled trial that aims to compare the efficacy and safety of the concurrent neoadjuvant chemotherapy with endocrine therapy and neoadjuvant chemotherapy alone in ER-positive, HER2-negative breast cancer.
Detailed Description
Data showed that concurrent neoadjuvant chemotherapy with endocrine therapy was a effective option for ER-positive, HER2-negative breast cancer patients. However this is still a controversial issue. The present study is an open-label randomized controlled clinical trial that aims to investigate the efficacy of concurrent NCT with endocrine therapy (AI with or without GnRH-a) in patients with ER-positive, HER2-negative breast carcinoma.
Investigators
Zhimin Shao
Director of Department of Surgical Oncology,Cancer Hospital & Institute
Fudan University
Eligibility Criteria
Inclusion Criteria
- •Estrogen receptor-positive and HER2-negative breast cancer patients, with histological stage of IIa-IIIc.
- •Without previous chemotherapy or endocrine therapy.
- •ECOG scores of 0-2 points
- •With measurable and evaluable breast tumor pathologically confirmed as invasive ductal carcinoma
- •Age: 18-70 years
- •Lateral breast cancer
- •Normal or acceptable kidney, liver, cardiovascular, and bone marrow functions
Exclusion Criteria
- •Pregnant women or nursing mothers
- •With distant metastasis
- •With a history of malignant tumor or complicated with other malignant tumors in addition to breast cancer, except for non-melanoma skin cancer, in situ cervical cancer or other cured malignant tumor without the basis of recurrence for at least five years
- •With mental illness or other conditions affecting the patient compliance
- •With other serious diseases or medical conditions:
- •Congestive heart failure or unstable angina pectoris, myocardial infarction within 6 months before the enrollment, uncontrolled hypertension and uncontrolled high-risk arrhythmia considered by the investigator
- •Obvious neurological or psychiatric disorders, including psychosis, epileptic dementia and other diseases may affect the understanding and sign of the informed consent for
- •Uncontrolled acute infection
- •Concurrent use of other investigational drugs; or participating in other clinical trials involving investigational drugs within 30 days before this study
- •With allergic constitution and any known or suspected drug allergy
Arms & Interventions
neoadjuvant chemo-endocrine therapy
In the experimental arm, patients received concurrent chemotherapy (fluorouracil 500mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 500mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 100mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles) with endocrine therapy (letrozole with or without leuprorelin) as a neoadjuvant treatment
Intervention: letrozole, leuprorelin, fluorouracil, epirubicin, cyclophosphamide, docetaxel
neoadjuvant chemotherapy alone
In the control group, patients received neoadjuvant chemotherapy alone (fluorouracil 500mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 500mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 100mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles)
Intervention: fluorouracil, epirubicin, cyclophosphamide, docetaxel
Outcomes
Primary Outcomes
objective response rate (ORR)
Time Frame: 4 years
the proportion of patients achieving clinical complete response and partial response in the breast based on magnetic resonance imaging
Secondary Outcomes
- pathological response rate(4 years)
- Progression-free survival (DFS)(6 years)
- Incidence of Serious Treatment-Emergent Adverse Events(grade 3 or 4)(4 years)
- Ki67 proliferation marker changes(4 years)
- pathologic complete response (pCR)(4 years)