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NSABP B-39 - "A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer"
Sites need approval - check RT requirements in protocol
Effective 12/30/06 Accrual is closed to: 1) women Age >50 w/DCIS regardless of hormone-receptor status, and 2) Women w/invasive breast cancer who meet all of following: age >50, node-negative, & hormone-receptor positive.
Treatment Plan (Supplied Drug: N/A)
Group 1 - Whole Breast Irradiation (WBI)
If chemo indicated: Chemo followed by WBI
If chemo not indicated: WBI alone
WBI
50Gy (2Gy/fraction)
OR
50.4Gy (1.8Gy/fraction)
To whole breast, followed by optional boost to 60.0-66.6Gy. No brachytherapy boosts.
Group 2 - partial Breast Irradiation (pBI)
Method of catheter placement up to physician's discretion and RO facility credentialing.
Adjuv chemo may be given at investigator's discretion following PBI.
PBI by Multi-Catheter Brachytherapy
34Gy in 3.4Gy fractions
PBI by Mammosite Balloon Catheter
34Gy in 3.4Gy fractions
PBI by 3D Conformal External Beam RT (3D-CRT)
38.5Gy in 3.85Gy fractions
FOR ALL PBI TECHNIQUES: RT given to tissue surrounding lumpectomy cavity only, BID (w/fx separation of >6 hrs), total 10 txs given on 5 days over 5-10 days
Eligibility
Age >18.
Life expectancy >10 yrs, excluding dx of breast cancer. (Consider cormorbid conditions, but not breast cancer dx.)
Must have Stg 0, I, or II breast cancer. If Stage II, tumor size must be <3cm.
Must be DCIS or invasive breast adenocarcinoma on histol exam.
Surgical tx of breast must have been lumpectomy. Margins of resected specimen must be histol-free of tumor (DCIS & invasive). Re-excision of surgical margins is allowed.
Gross disease must be unifocal w/path (invasive &/or DCIS) tumor <3cm. Pts w/microscopic multifocality are eligible if total path tumor size <3cm.
Pts w/invasive breast cancer must have axillary staging which can include sentinel node bx alone (if sentinel node -), sentinel node bx followed by axillary dissection or sampling w/minim 6 axillary nodes (if sentinel node +), or axillary dissection alone (w/minim 6 axillary nodes). Axillary staging not required for pts w/DCIS.
Must be randomized w/i 42 days following last surgery for breast cancer.
Must have ER analysis performed on primary tumor pre-randomiz. If ER-, then PgR analysis must be performed. If ER+, PgR is desired but not mandatory. "Marginal" or "borderline" results will be considered positive regardless of methodology.
Target lumpectomy cavity must be clearly delineated and target lumpectomy cavity/whole breast reference volume must be <30% based on post-op/pre-randomiz CT.
Based on post-op/pre-randomiz CT, PBI must be judged to be technically deliverable by a technique for which RO facility has been credentialed.
H&P <4 mos pre-randomiz and bilat mammogram <6 mos pre-randomiz.
Non-breast malignancies are allowed if disease-free >5 yrs pre-randomiz and at low risk for recurrence (physician's opinion). Following cancers allowed if diagnosed and treated w/i past 5 yrs: in situ carcinomas of cervix or colon, melanoma in situ, or non-melanoma skin cancer.
No male pts.
No >3 histol-positive axillary nodes.
No axillary nodes w/definite evidence of microscopic or macroscopic extracapsular extension.
No positive non-axillary sentinel node(s). Intramammary nodes are staged as axillary nodes.
No palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless histol-confirmed as negative for tumor.
No suspicious microcalcification, densities, or palpable abnormalities (in ipsilateral or contralateral breast) unless biopsied and found benign.
No non-epithelial breast malignancies (i.e., sarcoma, lymphoma).
No proven multicentric carcinoma (DCIS or invasive) in >1 quadrant or separated by >4cm.
No Paget's disease of nipple.
No synchronous bilat invasive or non-invasive breast cancer.
No hx of invasive breast cancer or DCIS. Hx of LCIS treated by surgery alone is allowed.
No surgical margins that cannot be microscopically assessed or are positive at path eval (re-excision allowed).
No plan for regional nodal RT.
No tx w/RT, chemo, biotherapy, &/or hormonal therapy for currently diagnosed breast cancer pre-randomiz. Only exception is hormonal therapy (given <28 days total, anytime after dx and b/f randomiz). For pts who will be receiving chemo, hormonal therapy must stop at or b/f randomiz and resume following completion of chemo. For pts not receiving chemo, hormonal therapy may continue.
No current therapy w/hormonal agents such as raloxifene, tamoxifen, or other SERMs either for osteoporosis or breast cancer prevention. Pts eligible if these meds are discontinued pre-randomiz.
No breast implants. Pts w/removed implants are eligible.
No prior breast or thoracic RT for any condition.
No collagen vascular disease (dermatomyositis w/CPK level above normal or w/active skin rash, systemic lupus erythematosis, or scleroderma).
No pregnant or lactating women. Women of reproductive potential must use effective, non-hormonal contraception.
No psychiatric or addictive disorders, or other conditions that would preclude study compliance (investigator's opinion).
PRESTUDY REQUIREMENTS:
H&P (w/i 4 mos pre-randomiz), wt
Breast asmt/exam*
Menopausal status
CBC/platelets#
Alk phos, SGOT or SGPT#
Pregnancy test (serum ßHCG) - if applicable, w/i 2 wks pre-randomiz
Chest CT or CXR
Abdominal CT (if hepatomegaly or alk phos, SGOT or SGPT, or bili >ULN for lab)
Ipsilateral breast CT (w/i 14 days post-surg, but anytime post-surg & b/f entry is acceptable)
Bone scan (if alk phos elevated &/or pain/symptoms suggestive of skeletal mets)
Bilat mammogram (w/i 6 mos pre-randomiz)
Serum collection (w/pt's consent, post-randomiz but b/f therapy begins)
* Post-op
# Pre- or post-op
Signed informed consent.