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Accelerated Radiation Therapy After Surgery in Treating Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT01417286
Recruitment Status : Active, not recruiting
First Posted : August 16, 2011
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
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 Radiation: External beam radiation therapy Phase 2

Detailed Description:


I. Freedom from local failure and freedom from regional failure.


I. Acute toxicity and late toxicity using previously published toxicity scales. II. To identify co-variates responsible for poor cosmetic outcome in women with reconstructed chest walls when treated with accelerated, hypofractionated radiotherapy.

III. To correlate toxicity, cosmesis, and local control with molecular markers.


Patients undergo hypofractionated accelerated RT 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.

After completion of study treatment, patients are followed up at 2-8 weeks, every 3-6 months for 3 years, every 6-12 months for 2 years, and then annually thereafter.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accelerated, Hypofractionated Post-Mastectomy Radiation Therapy in Women With Breast Cancer: A Phase II Trial
Study Start Date : December 2010
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Radiation Therapy
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
Hypofractionated accelerated radiation therapy over 11 days
Other Name: EBRT

Outcome Measures

Primary Outcome Measures :
  1. Time to local, regional, and/or distant failure [ Time Frame: Up to 5 years after dose of last treatment ]
    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.

Secondary Outcome Measures :
  1. Number and grade of adverse events experienced by patients [ Time Frame: Up to 5 years after last dose of treatment ]
    Adverse events will be monitored 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.

  2. Number of patients requiring a surgical revision of their reconstruction [ Time Frame: Up to 5 years after dose of last treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417286

United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, Utah
Huntsman Cancer Hospital
Salt Lake City, Utah, United States, 84103
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Principal Investigator: Bruce Haffty, MD Rutgers Cancer Institute of New Jersey
More Information

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01417286     History of Changes
Other Study ID Numbers: 041001
NCI-2011-01124 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Ductal, Breast
Inflammatory Breast Neoplasms
Carcinoma, Lobular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Carcinoma, Ductal
Neoplasms, Ductal, Lobular, and Medullary