Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery

NCT01082211 | Completed Phase 2 Results DMC

• 2 other identifiers: RTOG 1014CDR0000666991
• Study Type: interventional
• Target: 65
• Locations: 2 countries
• Sites: 58

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery kill any remaining tumor cells and may be an effective treatment for breast cancer. PURPOSE: This phase II trial is studying how well radiation therapy works in treating women with locally recurrent breast cancer previously treated with repeat breast-conserving surgery.

Conditions

Breast Cancer

Keywords

invasive ductal breast carcinoma; medullary ductal breast carcinoma with lymphocytic infiltrate; invasive lobular breast carcinoma; tubular ductal breast carcinoma; mucinous ductal breast carcinoma; ductal breast carcinoma in situ; lobular breast carcinoma in situ; recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events

  Adverse events (AEs) were graded with Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Based on a rate of 4% for the AEs of interest, a rate of ≥ 13% for these AEs with re-irradiation would be unacceptable. A sample size of 55 evaluable pts (eligible \& started protocol treatment) would provide: 86% power to conclude an unacceptable rate of the specified AEs, if the true AE rate was at least 13%; 93% probability to not conclude an unacceptable rate of the specified AEs, if the true AE rate is 4%. If ≥ 5 pts have treatment-related AEs, then the treatment-related AE rate was considered unacceptable.

  From the end of radiation to 1 year.

Secondary Outcomes (12)

• In-breast Recurrence

  From registration to date of recurrence or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.

• Freedom From Mastectomy

  From registration to date of mastectomy or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.

• Number of Patients With Detectable/Undetectable/Unevaluable Circulating Tumor Cells (CTCs)

  Prior to the start of radiation and 3 weeks after last radiation treatment.

• Treatment-related Adverse Events (AEs) Any Time

  From the end of radiation to end of follow-up. Will be evaluated at the time of the primary analysis.

• Distant Metastasis-free Survival

  From registration to date of distant metastasis, death or last follow-up. Analysis occurs after all patient have been potentially followed for 3 years.

Study Arms (1)

Partial Breast Re-Irradiation

EXPERIMENTAL

Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total

Radiation: 3D-Conformal External Beam

Interventions

3D-Conformal External Beam RADIATION

Radiation was to be delivered in 2 fractions per day, each of 1.5 Gy, separated by at least six hours, given in 15 consecutive working days to a total of 30 fractions and 45 Gy. Radiation was to be prescribed to the treatment unit isocenter, positioned at the approximate center of the planning target volume.

Partial Breast Re-Irradiation

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed locally recurrent breast carcinoma consistent with the following cell types: * Invasive ductal breast carcinoma * Medullary ductal breast carcinoma * Tubular ductal breast carcinoma * Mucinous ductal breast carcinoma * Lobular breast carcinoma * Ductal carcinoma in situ (DCIS) * No Paget disease of the nipple * Target lumpectomy cavity must be clearly defined and the target lumpectomy cavity/ whole-breast reference volume must be \< 30% based on a post-operative, pre-treatment CT scan * Tumor size ≤ 3 cm in greatest dimension on pathologic specimen * Negative histologic margins of resection and no tumor on ink following breast-preserving surgery of local recurrence (Re-excision is permitted to achieve negative margins) * Axilla negative or ≤ 3 positive lymph nodes without extracapsular extension * If the in-breast recurrence is DCIS and/or microinvasive disease, a sentinel lymph node (SLN) evaluation is not required, but if performed: * Patients with a negative sentinal lymph node (SLN) biopsy are eligible for enrollment * Patients with a positive SLN biopsy require an axillary lymph node (ALN) dissection (ALND is not required if the SLN is not identified) * Patient is eligible if 0-3 positive ALNs without extracapsular extension is documented * If the in-breast recurrence is invasive disease and: * No prior ALN dissection or SLN dissection only: * Patient is required to undergo axillary evaluation with either a SLN or ALN dissection * If the SLN is not identified or if the SLN is positive for metastatic disease then an ALN dissection is required * Patient is eligible for enrollment if encounter 0-3 positive lymph nodes without extracapsular extension * • Prior ALN dissection: negative clinical exam: patient is eligible for enrollment * It is recommended, but not required, that the patient undergo ultrasound evaluation of the axilla and the lymph node draining regions of the breast; any suspicious areas are to be biopsied and if positive followed with an ALN dissection * Patient is eligible for enrollment if biopsies are negative or 0-3 axillary lymph nodes without extracapsular extension are encountered * Prior ALN dissection: positive clinical exam: biopsy required * If biopsy is negative, patient is eligible for enrollment * If biopsy is positive an ALN dissection is required * Patient is eligible for enrollment if biopsies are negative or 0-3 axillary lymph nodes without extracapsular extension encountered * Ipsilateral breast mammogram and MRI within 120 days prior to study entry * Contralateral breast mammogram within 12 months of study entry * For invasive in-breast recurrence, no more than 120 days since whole-body (positron emission tomography) PET-CT scan OR CT scan of the chest, abdomen, and pelvis, and bone scan * No multicentric ipsilateral breast recurrence or regional recurrence (other than axilla) * Patients must have a breast technically amenable to partial-breast irradiation * No metastatic disease documented by physical exam or radiographic evaluation (for patients with invasive disease) * No skin involvement * No prior contralateral mastectomy * Estrogen and progesterone status must be known PATIENT CHARACTERISTICS: * Zubrod performance status 0-1 * Menopausal status not specified * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other invasive malignancy within the past 3 years except ipsilateral breast cancer and/or nonmelanoma skin cancer * No collagenous diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis * No psychiatric or addictive disorders that would preclude obtaining informed consent PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 2 weeks since prior chemotherapy and recovered * No concurrent intensity-modulated radiotherapy * No concurrent chemotherapeutic agents, including trastuzumab

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• NRG Oncology: collaborator

Study Sites (58)

Arizona Center for Cancer Care - Peoria

Peoria, Arizona, 85381, United States

Location

Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

Burbank, California, 91505, United States

Location

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

JFK Medical Center

Atlantis, Florida, 33462, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Cancer Institute at St. John's Hospital

Springfield, Illinois, 62702, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

St. Agnes Hospital Cancer Center

Baltimore, Maryland, 21229, United States

Location

Central Maryland Oncology Center

Columbia, Maryland, 21044, United States

Location

Tate Cancer Center at Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061, United States

Location

Cape Cod Hospital

Hyannis, Massachusetts, 02601, United States

Location

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, 48106-0995, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, 49017, United States

Location

McLaren Cancer Institute

Flint, Michigan, 48532, United States

Location

Butterworth Hospital at Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, 49503, United States

Location

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, 48236, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

Seton Cancer Institute at Saint Mary's - Saginaw

Saginaw, Michigan, 48601, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Barnes-Jewish West County Hospital

St Louis, Missouri, 63141, United States

Location

Memorial Sloan-Kettering Cancer Center - Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

St. Barnabas Medical Center Cancer Center

Livingston, New Jersey, 07039, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740-6395, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

Marlton, New Jersey, 08053, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Sands Cancer Center

Canandaigua, New York, 14424, United States

Location

Memorial Sloan-Kettering Cancer Center

Commack, New York, 11725, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032, United States

Location

Highland Hospital of Rochester

Rochester, New York, 14620, United States

Location

University Radiation Oncology at Parkridge Hospital

Rochester, New York, 14626, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Memorial Sloan-Kettering Cancer Center - Rockville Centre

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

Sleepy Hollow, New York, 10591, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Summa Center for Cancer Care at Akron City Hospital

Akron, Ohio, 44309-2090, United States

Location

Barberton Citizens Hospital

Barberton, Ohio, 44203, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267, United States

Location

Flower Hospital Cancer Center

Sylvania, Ohio, 43560, United States

Location

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Delaware County Regional Cancer Center at Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141, United States

Location

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Community Memorial Hospital Cancer Care Center

Menomonee Falls, Wisconsin, 53051, United States

Location

Columbia Saint Mary's Hospital - Ozaukee

Mequon, Wisconsin, 53097, United States

Location

Columbia-Saint Mary's Cancer Care Center

Milwaukee, Wisconsin, 53211, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Ductal, Breast; Carcinoma, Lobular; Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ

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; Carcinoma in Situ

Results Point of Contact

• Title: Wendy Seiferheld, M.S.
• Organization: NRG Oncology

seiferheldw@nrgoncology.org

Study Officials

• Douglas W. Arthur, MD

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 8, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: May 20, 2022
• Last Updated: June 21, 2022
• Results First Posted: June 8, 2017

Record last verified: 2022-05

Locations

CA (1); US (57)