N/A
Completed N=71
Radiation Therapy During Surgery in Treating Older Women With Invasive Breast Cancer
Source: ClinicalTrials.gov NCT00182728 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Physician — 45 Participants
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation during surgery may be an effective treatment for breast cancer.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for invasive breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Physician |
45 | — |
| PRIMARY Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Patients |
32 | — |
| PRIMARY Incidence of Grade 3/4 Toxicity |
— | — |
| PRIMARY Ipsilateral Breast Recurrence |
13 | — |
| SECONDARY Association of Phosphorylated Epidermal Growth Factor Receptor (EGFR) , Human Epidermal Growth Factor Receptor 2 (HER2), p44/42 Mitogen-activated Protein Kinase (MAPK), and Protein Kinase B (Akt) in Breast Tumors and Normal Tissue Before and After IORT |
— | — |
| SECONDARY Association of Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells (NFkB) Expression in Tumor and Normal Tissue Before and After IORT |
— | — |
| SECONDARY Association of Nuclear p53 Expression in Tumor and Normal Tissue Before and After IORT |
— | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary invasive ductal carcinoma of the breast
- Tumor size ≤ 3 cm
- No extensive intraductal component
- Tumor must not be attached to the skin, underlying muscle, or chest wall
- Candidate for breast-conserving therapy, as determined by the surgical and radiation oncologist
- Tumor amenable to segmental mastectomy (i.e., lumpectomy)
- No bilateral breast cancer
- No clinical or radiographic multifocal disease not amenable to single segmental mastectomy
- Patients with > 1 tumor mass in the same breast must have only 1 mass that is histologically malignant AND all other masses must be proven histologically benign
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 48 and over
Sex
- Female
Menopausal status
- Not specified
Performance status
- 0-2
Life expectancy
- At least 5 years
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant
- Fertile patients must use effective contraception
- No collagen vascular disease
- No medical condition that would preclude surgery
- Other prior malignancy allowed provided the following criteria are met:
- Patient has undergone potential curative therapy for all prior malignancies
- There is no evidence of any prior malignancy within the past 5 years
- Patient is deemed to be at low risk for recurrence of prior malignancy, as determined by the treating physician
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for this malignancy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to the breast
Surgery
- No breast implants
Data sourced from ClinicalTrials.gov (NCT00182728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.