Clinical Trial: NCT00966888 - My Cancer Genome

NCT00966888

Description:

RATIONALE: Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective than observation after mastectomy in treating women with stage II breast cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with standard therapy in treating women with stage II breast cancer who have undergone mastectomy.

Related Conditions:

Breast Carcinoma

Recruiting Status:

Unknown status

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT00966888

Trial Eligibility

Document

Title

Brief Title: Radiation Therapy or Standard Therapy in Treating Women With Stage II Breast Cancer Who Have Undergone Mastectomy
Official Title: Selective Use of Postoperative Radiotherapy AftEr MastectOmy - SUPREMO

Clinical Trial IDs

ORG STUDY ID: MRC-BIG2-04
SECONDARY ID: CDR0000642751
SECONDARY ID: ISRCTN61145589
SECONDARY ID: EU-20943
NCT ID: NCT00966888

Conditions

Breast Cancer

Purpose

Detailed Description

      OBJECTIVES:

        -  Determine the overall survival of women at intermediate risk for locoregional recurrence
           of breast cancer treated with ipsilateral chest wall adjuvant radiotherapy after
           mastectomy.

      OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Beginning 12 weeks after mastectomy or 6 weeks after adjuvant chemotherapy,
           patients undergo radiotherapy 5 days a week for 3-5 weeks in the absence of disease
           progression or unacceptable toxicity.

        -  Arm II: Patients receive standard of care and observation only. After completion of
           study therapy, patients are followed up twice in the first year, and then annually for
           up to 10 years.

Trial Arms

Name	Type	Description	Interventions
Arm I	Experimental	Beginning 12 weeks after mastectomy or 6 weeks after adjuvant chemotherapy, patients undergo radiotherapy 5 days a week for 3-5 weeks in the absence of disease progression or unacceptable toxicity.
Arm II	Active Comparator	Patients receive standard of care and observation only.

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed unilateral invasive breast cancer

               -  pT1, pN1, M0 disease

               -  pT2, pN1, M0 disease

               -  pT2, pN0 disease with grade III histology and/or lymphovascular invasion

               -  Multifocal breast cancer meeting both of the following criteria:

                    -  Largest discrete tumor ≥ 2 cm if N0

                    -  Grade III histology and/or lymphovascular invasion

          -  No bilateral breast cancer

          -  Axillary node negative status by axillary clearance, axillary node sampling, or
             sentinel node biopsy

               -  Patients with axillary node positive (1-3 positive nodes, including
                  micrometastases* > 0.2 mm and ≤ 2 mm) must have had an axillary node clearance
                  (minimum of 10 nodes removed) performed

                    -  No more than 3 pathologically involved lymph nodes

               -  No internal mammary nodes visible on sentinel node scintigraphy in the absence of
                  negative histology NOTE: *Isolated tumor cells not counted as micrometastases

          -  Underwent total mastectomy (with minimum of 1 mm margin clear of invasive cancer and
             DCIS) and axillary surgery with staging procedure

               -  Must have undergone adjuvant systemic chemotherapy if indicated for
                  intermediate-risk breast cancer

               -  Patients undergoing immediate breast reconstruction allowed

          -  No known BRCA1 and BRCA2 carriers

          -  Hormone receptor status not specified

        PATIENT CHARACTERISTICS:

          -  Menopausal status not specified

          -  Not pregnant

          -  Fit for adjuvant chemotherapy, adjuvant endocrine therapy, and post-operative
             radiotherapy

          -  No prior or concurrent malignancy except curatively treated nonmelanomatous skin
             cancer or carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No concurrent trastuzumab

          -  No prior neoadjuvant systemic therapy

Maximum Eligible Age:	N/A
Minimum Eligible Age:	N/A
Eligible Gender:	Female
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Overall survival
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Secondary Outcome Measures

Measure:	Chest wall recurrence
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Measure:	Regional recurrence
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Measure:	Disease-free survival
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Measure:	Metastasis-free survival
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Measure:	Cause of death (breast cancer, or intercurrent disease [cardiovascular or non-cardiovascular])
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Measure:	Quality of life
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Measure:	Cost effectiveness
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Details

Phase:	Phase 3
Primary Purpose:	Interventional
Overall Status:	Unknown status
Lead Sponsor:	Medical Research Council

Trial Keywords

stage II breast cancer

Last Updated

August 12, 2013

Clinical Trials /

Radiation Therapy or Standard Therapy in Treating Women With Stage II Breast Cancer Who Have Undergone Mastectomy