Clinical Trials: Breast Cancer

NSABP B-39 / RTOG 0413:

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

Inclusion/Exclusion:

• Subjects will be women only with DCIS or invasive adenocarcinoma of the breast
• Stage 0, I, or II breast cancer; if stage II, tumor size < 3 cm
• Subjects with invasive breast cancer (but not DCIS) must have axillary staging
• No more than 3 positive axillary nodes; no positive or suspicious non-axillary sentinel nodes
• Gross disease must be unifocal (microscopic multifocality acceptable if total size is < 3 cm)
• Lumpectomy with margins histologically free of tumor (re-excision of margins is permitted); randomization must be within 42 days following the last surgery
• ER analysis must be performed on primary tumor prior to randomization; if ER (-), then PgR analysis must be performed; if ER (+), PgR is desired but not mandatory
• Target lumpectomy cavity must be clearly delineated and the target lumpectomy cavity/whole breast reference volume must be < 30% based on post-op/pre-randomization CT scan
• PBI (via 3D-CRT or MammoSite) must be deemed technically feasible based on CT scan

Details: Randomization will be to one of the following treatments:

• Arm 1 (WBI): WBI will take place after any planned chemo, once daily for 5–7 weeks
• Arm 2 (PBI): PBI will take place prior to any planned chemo, twice daily (~ 6 hrs apart) on 5 days; SUNY Upstate is certified to use MammoSite or 3D-CRT for this part of the study

Chemotherapy and hormonal therapy are at the physician’s discretion. Intention to use or omit chemotherapy must be declared prior to randomization.

Subjects may also choose to participate in optional quality-of-life, cosmesis, and specimen submission components of this study.

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Carol M. Baldwin Breast Cancer Research Foundation:

Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

Inclusion/Exclusion:

• Subjects will be women who previously underwent breast preservation treatment (lumpectomy followed by external beam radiation therapy) for breast cancer
• Subjects must have been between the ages of 45 and 65 at the time of their radiation therapy
• Radiation therapy must have been completed at least 2½ years prior to study enrollment

Details: Some patients who undergo radiation therapy to the breast develop significant late skin and soft tissue changes resulting in poor cosmetic outcomes. Currently, there is no reliable test which can predict which patients will develop these reactions. The purpose of this study is to determine whether a promising but unproven new predictive blood test is effective in identifying these patients, so that they can be offered treatments which will provide improved cosmetic results.

• Each subject will be examined independently by two physicians, who will assess the degree to which ten separate late radiation effects are present
• Three tubes of blood will be drawn from each subject; these blood samples will subsequently be radiated, and the outcomes will be correlated with results of the subject’s physical exam
• Compensation of $25 will be provided to each subject participating in this study

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