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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
standard follow-up care
radiation therapy
Sponsored by
Medical Research Council
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

  • Edinburgh Cancer Centre at Western General HospitalRecruiting
  • Royal Infirmary - CastleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I

Arm II

Arm Description

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.

Patients receive standard of care and observation only.

Outcomes

Primary Outcome Measures

Overall survival
Acute and late morbidity

Secondary Outcome Measures

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

Full Information

First Posted
August 26, 2009
Last Updated
August 9, 2013
Sponsor
Medical Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT00966888
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medical Research Council

4. Oversight

5. Study Description

Brief Summary
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.
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.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
3500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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 Title
Arm II
Arm Type
Active Comparator
Arm Description
Patients receive standard of care and observation only.
Intervention Type
Procedure
Intervention Name(s)
standard follow-up care
Intervention Description
No intervention
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
Chest wall radiotherapy
Primary Outcome Measure Information:
Title
Overall survival
Title
Acute and late morbidity
Secondary Outcome Measure Information:
Title
Chest wall recurrence
Title
Regional recurrence
Title
Disease-free survival
Title
Metastasis-free survival
Title
Cause of death (breast cancer, or intercurrent disease [cardiovascular or non-cardiovascular])
Title
Quality of life
Title
Cost effectiveness

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian H. Kunkler, MD
Organizational Affiliation
Edinburgh Cancer Centre at Western General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edinburgh Cancer Centre at Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian H. Kunkler, MD
Phone
44-131-537-2214
Email
i.kunkler@ed.ac.uk
Facility Name
Royal Infirmary - Castle
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter A. Canney, MD
Phone
44-141-211-1160

12. IPD Sharing Statement

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

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