Chemotherapy or Letrozole Before Surgery in Treating Postmenopausal Women With Breast Cancer That Can Be Removed By Surgery
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00963729
- Lead Sponsor
- Imperial College London
- Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. It is not yet known whether giving more than one drug (combination chemotherapy) or giving letrozole before surgery is more effective in treating women with breast cancer.
PURPOSE: This randomized phase III trial is studying giving combination chemotherapy before surgery to see how well it works compared with letrozole given before surgery in treating postmenopausal women with breast cancer that can be removed by surgery.
- Detailed Description
OBJECTIVES:
* To compare the efficacy and tolerability of cytotoxic chemotherapy versus aromatase inhibition for the down-staging of strongly ER+ primary breast cancer in postmenopausal women.
* To identify biological predictors of response to these two treatment modalities.
OUTLINE: This is a multicenter pilot, feasibility study followed by a randomized study. In the pilot study, a record of all patients screened and invited to participate in the study is compiled. Reasons for failure to recruit will be recorded. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients who do not achieve at least partial response after 3 courses receive docetaxel IV on day 1 of 3-week courses for an additional 3 courses.
* Arm II: Patients receive oral letrozole daily for 18-23 weeks until day of surgery.
Patients in both arms undergo surgery at week 18-23. Most patients then receive adjuvant therapy.
Quality of life is assessed at baseline, periodically during study treatment, and then during follow up.
Blood is collected pre-treatment, at mid-treatment, and before surgery. Blood is then collected every 6 months for 2 years. Blood samples and preserved tumor samples are used for correlative studies.
After completion of surgery, patients are followed up at least annually for 10 years.
PROJECTED ACCRUAL: A total of 40 patients for the pilot study and 716 patients for the phase III study will be accrued.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 756
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm I epirubicin hydrochloride Patients receive fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Arm I cyclophosphamide Patients receive fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Arm I docetaxel Patients receive fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Arm I fluorouracil Patients receive fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Arm II letrozole Patients receive oral letrozole daily for 18-23 weeks until day of surgery.
- Primary Outcome Measures
Name Time Method Feasibility of patient recruitment (pilot) Feasibility of tissue collection (pilot) Ultrasound (or mammogram) response rate
- Secondary Outcome Measures
Name Time Method Clinical response rate Radiologic response rate by ultrasound (pilot) Quality of life Pathological complete response rate (pCR) defined as no residual invasive or pre-invasive carcinoma in breast or axilla (pilot) Plasma DNA changes in relation to treatment response Rate of conservation surgery Degree of pathological response Ki-67 changes and its relationship to treatment response Length of time to maximum response within the treatment period Tolerability of the various treatments Disease-free survival Overall survival MRI response
Trial Locations
- Locations (5)
St. Mary's Hospital
🇬🇧London, England, United Kingdom
Asan Medical Center - University of Ulsan College of Medicine
🇰🇷Seoul, Korea, Republic of
West Middlesex University Hospital
🇬🇧Isleworth, England, United Kingdom
Guy's Hospital
🇬🇧London, England, United Kingdom
Charing Cross Hospital
🇬🇧London, England, United Kingdom