Radiation Therapy in Treating Women With Early Stage Breast Cancer

NCT00909909 | Active Not Recruiting Phase 2 DMC

• 5 other identifiers: Pro20170001671CDR0000643276P30CA0727200220090059040807
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving it after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how well it works in treating women with early stage breast cancer.

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situ; invasive ductal breast carcinoma; invasive lobular breast carcinoma; medullary ductal breast carcinoma with lymphocytic infiltrate; mucinous ductal breast carcinoma; papillary ductal breast carcinoma; tubular ductal breast carcinoma; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

• Loco-regional control as assessed by physical examination, mammography, and other relevant imaging

  5 years

Secondary Outcomes (2)

• Toxicity (including seroma formation, brachial plexopathy, fat necrosis, pain, pigmentation, and telangiectasia) as assessed by NCI CTCAE v3.0

  5 years

• Cosmesis as assessed by the Breast Cancer Treatment Outcome Scale

  5 years

Study Arms (2)

A

ACTIVE COMPARATOR

3DCRT/IMRT lumpectomy bed boost followed by accelerated whole breast irradiation (AWBI)

Radiation: External beam boost; Radiation: whole breast irradiation

B

ACTIVE COMPARATOR

Accelerated whole breast irradiation (AWBI) followed by 3DCRT/IMRT lumpectomy bed boost

Radiation: External beam boost; Radiation: whole breast irradiation

Interventions

External beam boost RADIATION

3-dimensional conformal radiation therapy and intensity modulated radiation therapy

A; B

whole breast irradiation RADIATION

accelerated, hypofractionated whole breast irradiation

A; B

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer, including 1 of the following subtypes: * Ductal carcinoma in situ * Invasive ductal carcinoma * Invasive lobular carcinoma * Medullary carcinoma * Papillary carcinoma * Colloidal (mucinous) carcinoma * Tubular carcinoma * Pathological stage 0-IIIA disease (pTis; pT1-2, N0-N2a, M0) * Tumor size ≤ 5 cm * Breast considered technically satisfactory for radiotherapy * Has undergone lumpectomy or mastectomy and either sentinel node biopsy or axillary dissection (if invasive carcinoma is present) * Negative inked histological margins (i.e., no invasive cells at surgical margin) or confirmed negative re-excision specimen * Unifocal or multifocal (confined to 1 quadrant; tumors \< 4 cm apart) disease with 1 or 2 foci that can be encompassed by 1 lumpectomy * No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by ≥ 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy * No evidence of suspicious microcalcifications in the breast before the start of radiotherapy * If malignancy-associated microcalcifications were initially present, the post-excision mammography must be negative * No more than 9 positive axillary lymph nodes * No palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor * No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer * No lobular carcinoma in situ alone (i.e., no invasive component) or non-epithelial breast malignancies (e.g., sarcoma or lymphoma) * No Paget disease of the nipple * No skin involvement, regardless of tumor size * No distant metastases * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Pre- or post-menopausal * ECOG performance status 0-1 * No co-existing medical condition that would limit life expectancy to \< 2 years * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except for nonmelanoma skin cancer (the disease-free interval from any prior malignancy must be continuous) * No collagen vascular disease, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis * No psychiatric or addictive disorder that would preclude obtaining informed consent PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior radiotherapy for the current breast cancer * No tylectomies so extensive that the cosmetic result is low or poor prior to radiotherapy * Chemotherapy allowed provided the following criteria are met: * Chemotherapy is not administered prior to, during, and for ≥ 21 days after completion of radiotherapy (for patients receiving brachytherapy boost) * Chemotherapy is not administered for ≥ 21 days before, during, and for ≥ 21 days after completion of radiotherapy (for patients receiving external beam radiotherapy boost or chest wall irradiation) * Concurrent tamoxifen, anastrozole, or other hormonal therapy allowed * May be initiated before, during, or after radiotherapy * No other concurrent chemotherapy, immunotherapy, or experimental medications

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

Sponsors & Collaborators

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

Study Sites (4)

RWJBarnabas Health - Robert Wood Johnson University Hospital

Hamilton, New Jersey, 08690, United States

Location

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08690, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

RWJBarnabas Health - Robert Wood Johnson University Hospital

Somerset, New Jersey, 08873, United States

Location

Related Publications (2)

• Chakraborty MA, Sherwani ZK, Narra LR, Abou Yehia Z, Ohri N, Cui T, Eladoumikdachi F, Kowzun MJ, Kumar S, Potdevin L, Toppmeyer DL, Haffty BG. Preoperative Radiation Boost Results in Low Rates of Re-excision and Reduced Locoregional Treatment Time in Breast Cancer Patients. Ann Surg Oncol. 2025 Dec;32(13):9836-9842. doi: 10.1245/s10434-025-18089-9. Epub 2025 Aug 20.

  PMID: 40836156 DERIVED

• Ahlawat S, Haffty BG, Goyal S, Kearney T, Kirstein L, Chen C, Moore DF, Khan AJ. Short-Course Hypofractionated Radiation Therapy With Boost in Women With Stages 0 to IIIa Breast Cancer: A Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2016 Jan 1;94(1):118-125. doi: 10.1016/j.ijrobp.2015.09.011. Epub 2015 Sep 16.

  PMID: 26700706 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Bruce Haffty, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: May 29, 2009
• Study Start: May 13, 2009
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)