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Accelerated Radiation Therapy After Surgery in Treating Patients With Breast Cancer

Primary Purpose

Inflammatory Breast Cancer, Invasive Ductal Breast Carcinoma, Invasive Lobular Breast Carcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
External beam radiation therapy
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Rutgers Cancer Institute of New Jersey
  • Huntsman Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Count of Participants With Grade Three or Higher Toxicities
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.
Participants With Plans for Breast Reconstruction, Having Grade Three or Higher Reconstruction Complications

Full Information

First Posted
August 2, 2011
Last Updated
March 29, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT01417286
Brief Title
Accelerated Radiation Therapy After Surgery in Treating Patients With Breast Cancer
Official Title
Accelerated, Hypofractionated Post-Mastectomy Radiation Therapy in Women With Breast Cancer: A Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 21, 2010 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

4. Oversight

Data Monitoring Committee
No

5. 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
Detailed Description
PRIMARY OBJECTIVES: I. Freedom from local failure and freedom from regional failure. SECONDARY OBJECTIVES: 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. OUTLINE: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
External beam radiation therapy
Other Intervention Name(s)
EBRT
Intervention Description
Hypofractionated accelerated radiation therapy over 11 days
Primary Outcome Measure Information:
Title
Number of Participants With Local, Regional, and/or Distant Failure
Description
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.
Time Frame
Up to 5 years after dose of last treatment, an average of 62 months
Secondary Outcome Measure Information:
Title
Count of Participants With Grade Three or Higher Toxicities
Description
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.
Time Frame
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.
Title
Participants With Plans for Breast Reconstruction, Having Grade Three or Higher Reconstruction Complications
Time Frame
Up to five years after dose of last treatment, an average of 62 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Haffty, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Huntsman Cancer Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Accelerated Radiation Therapy After Surgery in Treating Patients With Breast Cancer

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