Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy

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Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

conventional surgery

radiation therapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, inflammatory breast cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier Etterbeek Ixelles
U.Z. Gasthuisberg
Instituto de Radiomedicina
Rambam Medical Center
Akademisch Medisch Centrum
Arnhems Radiotherapeutisch Instituut
Leiden University Medical Center
Dr. Bernard Verbeeten Instituut
Medical University of Gdansk
Karol Marcinkowski University
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Hospitais da Universidade de Coimbra (HUC)
Charing Cross Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00028704

First Posted

January 4, 2002

Last Updated

July 17, 2012

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Central and Eastern European Oncology Group, Grupo Oncologico Cooperativo Chileno de Investigation, International Collaborative Cancer Group

1. Study Identification

Unique Protocol Identification Number

NCT00028704

Brief Title

Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy

Official Title

Conservative Local Treatment Versus Mastectomy After Induction Chemotherapy In Locally Advanced Breast Cancer: A Randomized Phase III Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Terminated

Why Stopped

low accrual

Study Start Date

October 2001 (undefined)

Primary Completion Date

December 2003 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Central and Eastern European Oncology Group, Grupo Oncologico Cooperativo Chileno de Investigation, International Collaborative Cancer Group

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Breast-conserving treatments such as radiation therapy or limited surgery are less invasive than mastectomy and may improve the quality of life. It is not yet known if breast-conserving treatments are as effective as mastectomy followed by radiation therapy in treating locally advanced breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of breast-conserving therapy with mastectomy followed by radiation therapy in treating women who have locally advanced breast cancer that has been previously treated with chemotherapy.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, inflammatory breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials: