Chemotherapy or Letrozole Before Surgery in Treating Postmenopausal Women With Breast Cancer That Can Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00963729|
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: cyclophosphamide Drug: docetaxel Drug: epirubicin hydrochloride Drug: fluorouracil Drug: letrozole||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||756 participants|
|Masking:||None (Open Label)|
|Official Title:||A Neoadjuvant Study of Chemotherapy Versus Endocrine Therapy in Postmenopausal Patients With Primary Breast Cancer|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2011|
Experimental: 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.
Given IVDrug: docetaxel
Given IVDrug: epirubicin hydrochloride
Given IVDrug: fluorouracil
Experimental: Arm II
Patients receive oral letrozole daily for 18-23 weeks until day of surgery.
- Feasibility of patient recruitment (pilot)
- Feasibility of tissue collection (pilot)
- Ultrasound (or mammogram) response rate
- 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
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): NCT00963729
|Korea, Republic of|
|Asan Medical Center - University of Ulsan College of Medicine|
|Seoul, Korea, Republic of, 138-736|
|West Middlesex University Hospital|
|Isleworth, England, United Kingdom, TW7 6AF|
|London, England, United Kingdom, SE1 9RT|
|St. Mary's Hospital|
|London, England, United Kingdom, W2 1NY|
|Charing Cross Hospital|
|London, England, United Kingdom, W6 8RF|
|Study Chair:||R. Charles Coombes, MD, MRCP, FRCP, PhD, FMedSci||Charing Cross Hospital|