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Selective Use of Postoperative Radiotherapy AftEr MastectOmy - SUPREMO


Phase 3
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Selective Use of Postoperative Radiotherapy AftEr MastectOmy - SUPREMO


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:

No

Principal Investigator

Ian H. Kunkler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Edinburgh Cancer Centre at Western General Hospital

Authority:

Unspecified

Study ID:

CDR0000642751

NCT ID:

NCT00966888

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • Breast Neoplasms

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