Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery

NCT01754519 | Terminated Phase 2 Results DMC

• 3 other identifiers: I 108907NCI-2009-01568P30CA016056
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well radiation therapy works in treating post-menopausal women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for breast cancer.

Conditions

Ductal Breast Carcinoma In Situ; Estrogen Receptor Negative; Estrogen Receptor Positive; HER2/Neu Negative; Invasive Cribriform Breast Carcinoma; Invasive Ductal Carcinoma, Not Otherwise Specified; Lobular Breast Carcinoma In Situ; Mucinous Breast Carcinoma; Papillary Breast Carcinoma; Progesterone Receptor Positive; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIC Breast Cancer; Tubular Breast Carcinoma

Outcome Measures

Primary Outcomes (3)

• Number of Patients With Adverse Events as a Measure of Safety and Tolerability

  Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0.

  Up to 2 years

• Quality-of-life Assessments

  Will be rated by patients using the POST-B, the Functional Assessment of Chronic Illness Therapy (FACIT), and the Skindex-16.

  Up to 2 years

• Cosmetic Differences in the Treated Breast

  Will measure differences in the cosmetic size, shape, or texture of the breast. Cosmesis will be graded according to the Baker Scale. Patient reported cosmesis will also be evaluated using the Ontario Clinical Oncology Breast Cancer Questionnaire.

  Up to 2 years

Secondary Outcomes (3)

• Locoregional Control Rate

  At 5 years

• Overall Survival

  Up to 5 years

• Disease Specific Survival

  Up to 5 years

Study Arms (1)

Treatment (radiation therapy)

EXPERIMENTAL

Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.

Procedure: Therapeutic Conventional Surgery; Radiation: Radiation Therapy; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment

Interventions

Therapeutic Conventional Surgery PROCEDURE

Undergo wide local excision breast surgery

Treatment (radiation therapy)

Radiation Therapy RADIATION

Undergo SFRT

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, RT

Treatment (radiation therapy)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (radiation therapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (radiation therapy)

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Core needle biopsy (e.g. Mammotome, core, stereotactic, ultrasound guided) showing invasive mammary cancer (with or without concomitant ductal carcinoma or lobular carcinoma in situ) or ductal carcinoma in situ; acceptable histologic types of invasive mammary cancer include ductal, tubular, mucinous, papillary, cribriform and "NOS" (not otherwise specified); invasive lobular cancer is excluded
• Age \>= 50 years and postmenopausal with no menses for at least one year prior to study enrollment
• Age \> 70 years with invasive breast cancer clinical size =\< 3 cm OR Age 50 - 70 years with invasive breast cancer clinical size =\< 1.5 cm OR Age \>= 50 years and postmenopausal with any grade ductal carcinoma in situ (DCIS) clinical extent =\< 1.5 cm (clinical tumor size will be determined by pre-operative breast imaging-mammography, ultrasound and/or magnetic resonance imaging; in cases of multiple measurements, the largest recorded single dimension will be used to determine eligibility)
• Hormone receptor status
• Estrogen or progesterone receptor positive or
• Estrogen and progesterone receptor negative and clinical tumor size =\< 1.0 cm
• Human epidermal growth factor receptor 2 (HER2)/neu negative on the core biopsy analysis defined as 0 or 1+ by immunohistochemistry or not amplified by fluorescent in situ hybridization analysis
• Tumor \>= 0.5 cm from skin as defined by breast ultrasound
• Unicentric tumor
• Axillary lymph nodes negative by pre-operative physical examination in all cases and pathologic examination from surgery for invasive disease
• Negative surgical margins, defined as no margin-labeling ink on tumor cells from margin evaluation

You may not qualify if:

• Initial core biopsy showing invasive lobular cancer
• Estrogen receptor and progesterone receptor negative tumor with clinical size \> 1 cm
• Any Her 2+ breast cancer (immunohistochemistry 3+; or amplified by fluorescence in situ hybridization \[FISH\])
• Cancer in a patient with a known inherited susceptibility mutation in breast cancer (BRCA)1 or BRCA2
• Multicentric breast cancer (two foci of known cancer in the breast separated by greater than 5 cm, or in separate quadrants
• Clinically or pathologically positive axillary lymph nodes
• Any prior breast cancer
• Prior breast radiation therapy

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• Cianna Medical, Inc.: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

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

Interventions

Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Limitations and Caveats

The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• David Mattson

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: November 23, 2012
• First Posted: December 21, 2012
• Study Start: May 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 7, 2017
• Results First Posted: June 6, 2017

Record last verified: 2017-06

Locations

US (1)