Conservative Local Treatment Versus Mastectomy After Induction Chemotherapy In Locally Advanced Breast Cancer: A Randomized Phase III Study
N/A
N/A
Female
Breast Cancer
Trial Information
Conservative Local Treatment Versus Mastectomy After Induction Chemotherapy In Locally Advanced Breast Cancer: A Randomized Phase III Study
OBJECTIVES:
- Compare the overall survival and time to loco-regional failure in women with locally
advanced breast cancer treated with breast-conserving local therapy vs mastectomy
followed by radiotherapy after they have received prior induction chemotherapy.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, initial stage (T0, T1, T2, T3, or Tx vs T4), response to prior
induction chemotherapy (complete response (CR) vs other), and menopausal status
(premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo mastectomy followed by radiotherapy.
- Arm II: Patients receive breast-conserving treatment comprising 1 of 3 of the following
therapeutic options:
- Regimen A: Patients receive radiotherapy alone.
- Regimen B: Patients with a partial response (PR) to prior induction chemotherapy
undergo limited surgery followed by radiotherapy. Patients with a CR to prior
induction chemotherapy undergo radiotherapy alone.
- Regimen C: Patients with a partial response (PR) or CR to prior induction
chemotherapy undergo radiotherapy alone.
Patients with a CR to radiotherapy receive no further treatment. Patients with a PR to
radiotherapy undergo limited surgery.
Quality of life is assessed at baseline, at the end of therapy, every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.
Patients are followed within 1 month, every 3 months for 2 years, every 6 months for 3
years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,300 patients (650 per treatment arm) will be accrued for
this study within 5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed locally advanced breast cancer
- T3 inoperable, N0-N2
- Any T, N2
- T4, N0-N2
- Inflammatory breast carcinoma
- Prior treatment with 4-6 courses of standard induction chemotherapy or active
investigational regimens completed within the past 4 weeks
- Residual tumor size less than 5 cm
- No fixed axillary lymph nodes
- No multifocal or bilateral breast cancer
- No clinical suspicion of extensive ductal carcinoma in situ
- No unresolved skin edema
- No distant metastases (including ipsilateral supraclavicular node)
- Positive bone scan allowed provided there are no bone metastases on x-ray
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Any age
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- WHO 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 times normal
- SGOT and SGPT no greater than 2 times normal
- Alkaline phosphatase no greater than 2 times normal
Renal:
- Creatinine less than 1.5 times normal
Other:
- No other prior or concurrent malignancy except adequately treated squamous cell or
basal cell skin cancer or adequately treated cone-biopsied carcinoma in situ of the
cervix
- No serious underlying medical illness that would preclude study
- No psychiatric or addictive disorder that would preclude study
- No contraindication to study treatment
- Not pregnant
- Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- No concurrent hormonal replacement therapy
- No concurrent oral contraceptives
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy for breast cancer
Surgery:
- No prior surgery for breast cancer other than biopsy for diagnosis confirmation
Other:
- No other prior systemic therapy for breast cancer
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Jacek Jassem, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Medical University of Gdansk
Authority:
United States: Federal Government
Study ID:
EORTC-10974-22002
NCT ID:
NCT00028704
Start Date:
October 2001
Completion Date:
Related Keywords:
- Breast Cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- inflammatory breast cancer
- Breast Neoplasms
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