Accelerated Radiation Therapy After Surgery in Treating Patients With Breast Cancer

NCT01417286 | Completed Phase 2 Results

• 4 other identifiers: 041001NCI-2011-01124P30CA0727200220100204
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Inflammatory Breast Cancer; Invasive Ductal Breast Carcinoma; Invasive Lobular Breast Carcinoma; Mucinous Ductal Breast Carcinoma; Papillary Ductal Breast Carcinoma; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Tubular Ductal Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Local, Regional, and/or Distant Failure

  Assessed by physical examination and other relevant imaging per the discretion of the patients treating physicians. Confirmed by biopsy, and should be coded as either chest wall recurrence, axilla, supraclavicular, or internal mammary.

  Up to 5 years after dose of last treatment, an average of 62 months

Secondary Outcomes (2)

• Count of Participants With Grade Three or Higher Toxicities

  weekly during treatment, then two weeks after RT, then at week 8, then every 3-6 months for 3 years, then every 6-12 months out to 5 years.

• Participants With Plans for Breast Reconstruction, Having Grade Three or Higher Reconstruction Complications

  Up to five years after dose of last treatment, an average of 62 months

Study Arms (1)

Radiation Therapy

EXPERIMENTAL

Patients undergo hypofractionated accelerated radiation therapy over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

Radiation: External beam radiation therapy

Interventions

External beam radiation therapy RADIATION

Hypofractionated accelerated radiation therapy over 11 days

Also known as: EBRT

Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Rutgers Cancer Institute of New Jersey: collaborator

Study Sites (2)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Huntsman Cancer Hospital

Salt Lake City, Utah, 84103, United States

Location

MeSH Terms

Conditions

Inflammatory Breast Neoplasms; Carcinoma, Ductal, Breast; Carcinoma, Lobular; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

Results Point of Contact

• Title: Dr. Haffty
• Organization: Cancer Institute of New Jersey Rutgers

hafftybg@cinj.rutgers.edu

732-235-8675

Study Officials

• Bruce Haffty, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Radiation Oncology Radiation Oncology

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 16, 2011
• Study Start: December 21, 2010
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: April 20, 2023
• Results First Posted: April 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)