Phase 2
N=67
Accelerated Radiation Therapy After Surgery in Treating Patients With Breast Cancer
Inflammatory Breast Cancer · Invasive Ductal Breast Carcinoma · Invasive Lobular Breast Carcinoma · Mucinous Ductal Breast Carcinoma · Papillary Ductal Breast Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01417286 ↗Enrolled (actual)
67
Serious AEs
1.5%
Results posted
Apr 2023
Primary outcome: Primary: Number of Participants With Local, Regional, and/or Distant Failure — 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- External beam radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Local, Regional, and/or Distant Failure |
12 | — |
| SECONDARY Count of Participants With Grade Three or Higher Toxicities |
7 | — |
| SECONDARY Participants With Plans for Breast Reconstruction, Having Grade Three or Higher Reconstruction Complications |
15 | — |
Summary
This phase II trial studies how well giving accelerated radiation therapy (RT) after surgery works in treating patients with breast cancer. RT uses high energy x rays to kill tumor cells. Giving RT after surgery may kill any remaining tumor cells
Eligibility Criteria
Inclusion Criteria
- Invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies; invasive lobular carcinomas are allowed
- American Joint Committee for Cancer (AJCC) Stage IIa - IIIc (pathologic stage T0N1-3, T1N1-3, T2N1-3, T3N0-3, T4N0-3, all M0 status) histologically confirmed invasive carcinoma of the breast treated with mastectomy and either sentinel node biopsy or axillary dissection; inflammatory carcinoma (T4d) is allowed
- Patients with locally advanced breast cancer on clinical exam and diagnostics ( > 3 cm and/or clinically node-positive) who have mastectomy after induction chemotherapy are allowed
- Multifocal/multicentric disease is allowed
- Negative inked histologic margins of mastectomy (no invasive cells at margin) or positive margin at pectoralis fascia or skin
- Tamoxifen, Arimidex or other hormonal therapy is allowed; it may begin any time relative to the radiation at the discretion of the treating physician
- Chemotherapy is allowed, if chemotherapy is indicated the chemotherapy can be delivered first, followed by radiation therapy beginning 21-63 days after the last cycle of chemotherapy or the radiation therapy can be delivered first and the chemotherapy can be delivered no earlier than 21 days post radiation therapy; neoadjuvant chemotherapy is allowed; radiation therapy will be delivered after mastectomy or after any adjuvant chemotherapy as described above
- Chest wall reconstruction is allowed
- The patient must be enrolled and have treatment planning between 14-63 days from date of last surgery or last cycle of chemotherapy, and radiation must start within 21-63 days of date of last surgery or last cycle of chemotherapy
- Signed study-specific informed consent form prior to study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
- Patient with distant metastases (M1)
- Patients with ductal or lobular carcinoma in-situ alone (no invasive component) and patients with non-epithelial breast malignancies such as sarcoma or lymphoma
- Patient with T1N0 or T2N0 disease
- Prior radiation therapy to the chest
- Patients with collagen vascular diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
- Patients with co-existing medical conditions with life expectancy < 2 years
- Patients with psychiatric (with the possible exception of incompetence as defined by New Jersey [NJ] law) or addictive disorders that would preclude obtaining informed consent
- Other malignancy, except non-melanomatous skin cancer, < 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous
- Women who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females
- Women who are able to conceive and unwilling to practice an effective method of birth control; women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to treatment
Data sourced from ClinicalTrials.gov (NCT01417286). 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.