Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer

NCT00599989 | Completed DMC FDA Device

• 3 other identifiers: CDR0000581427UPCC-08104UPCC-IRB-801897
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy and how well it works in treating women undergoing breast conservation therapy for early-stage breast cancer.

Conditions

Breast Cancer; Long-term Effects Secondary to Cancer Therapy in Adults; Skin Reactions Secondary to Radiation Therapy

Keywords

long-term effects secondary to cancer therapy in adults; skin reactions secondary to radiation therapy; stage I breast cancer; stage II breast cancer; invasive lobular breast carcinoma with predominant in situ component; invasive lobular breast carcinoma; comedo ductal breast carcinoma; ductal breast carcinoma in situ; invasive ductal breast carcinoma; medullary ductal breast carcinoma with lymphocytic infiltrate; mucinous ductal breast carcinoma; papillary ductal breast carcinoma; tubular ductal breast carcinoma; Paget disease of the breast with intraductal carcinoma; Paget disease of the breast with invasive ductal carcinoma; breast cancer in situ

Outcome Measures

Primary Outcomes (1)

• Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy

  11 months

Secondary Outcomes (4)

• Late toxicity and cosmesis as assessed at or before 3 years from the start of radiotherapy and every 3 months during follow-up

  11 months

• Site of disease recurrence (i.e., local, regional, or distant)

  11 months

• Time to recurrence

  11 months

• Time to locoregional recurrence

  11 months

Study Arms (1)

APBI

EXPERIMENTAL

Procedure: adjuvant therapy; Procedure: conventional surgery; Radiation: 3-dimensional conformal radiation therapy; Radiation: brachytherapy; Radiation: intracavitary balloon brachytherapy; Radiation: proton beam radiation therapy

Interventions

adjuvant therapy PROCEDURE

APBI

conventional surgery PROCEDURE

APBI

3-dimensional conformal radiation therapy RADIATION

APBI

brachytherapy RADIATION

APBI

intracavitary balloon brachytherapy RADIATION

APBI

proton beam radiation therapy RADIATION

APBI

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Women who have chosen to undergo breast conservation therapy, including lumpectomy and breast irradiation, at the University of Pennsylvania for any invasive mammary carcinoma or intraductal breast cancer * Stage I-II invasive or intraductal breast cancer * Unifocal tumor ≤ 3.0 cm in size * Patients with microscopic multifocality are eligible provided total pathologic tumor size is ≤ 3 cm * No proven multicentric carcinoma in more than 1 quadrant or separated by 4 or more centimeters * Pre- or post-biopsy ipsilateral\* breast MRI negative for multicentric disease (i.e., areas of cancer that cannot be removed in a single excision specimen) or other suspicious findings NOTE: \*Patients with synchronous bilateral breast cancers who will be treated with radiotherapy to each breast are eligible, provided such treatment can be performed in a manner that avoids overlap between treatment fields. Both sides may be treated with partial breast irradiation (PBI) if the pathologic eligibility criteria are met for both tumors, or only one side may be treated with PBI if the criteria are met for only one tumor. * Negative margins of excision (≥ 2 mm) OR no tumor seen in a re-excision specimen * No extensive intraductal component present * Negative sentinel lymph node (SLN) or axillary lymph node dissection OR fewer than 4 positive nodes on adequate axillary lymph node dissection (i.e., 10 or more lymph nodes removed) * If a SLN is positive on hematoxylin and eosin (but not by immunohistochemistry alone), complete axillary lymph node dissection is required * Axillary lymph node staging is not required for patients with ductal carcinoma in situ * No SLN identified in the internal mammary nodes * No node \> 2 cm * No node with extracapsular extension * Surgical clips placed in the operative bed OR ability to visualize operative bed on CT scan of the breast * Target lumpectomy cavity/whole breast reference volume must be ≤ 30% based on the treatment planning CT scan * No diffuse calcifications on diagnostic mammogram * Negative post-biopsy mammogram required if presented with mammographically detected microcalcifications * Hormone receptor status unspecified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * History of non-breast malignancies allowed provided patients have been disease free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence * Treated carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, or basal cell and squamous cell skin cancer within the past 5 years allowed * Patients must agree to undergo breast MRI * No contraindication to MRI, including a pacemaker or other foreign body * Not pregnant or nursing * No technical impediment to appropriate dosimetry * No personal history of collagen vascular disease PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior in-field irradiation * No presence of breast implant * No breast reconstructive surgery prior to study entry * No prior neoadjuvant chemotherapy or hormonal therapy

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

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

Interventions

Chemotherapy, Adjuvant; Radiotherapy, Conformal; Brachytherapy; Proton Therapy

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; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma in Situ; Carcinoma, Ductal

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy, Computer-Assisted; Radiotherapy; Heavy Ion Radiotherapy

Study Officials

• Lilie Lin, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 24, 2008
• Study Start: January 1, 2005
• Primary Completion: May 11, 2009
• Study Completion: May 11, 2009
• Last Updated: April 9, 2020

Record last verified: 2019-04

Locations

US (1)