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Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01245712
Recruitment Status : Recruiting
First Posted : November 22, 2010
Last Update Posted : July 22, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase II trial studies the side effects and how well radiation therapy works in treating patients with stage 0-II breast cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

Condition or disease Intervention/treatment Phase
Breast Adenocarcinoma Ductal Breast Carcinoma In Situ Invasive Breast Carcinoma Stage 0 Breast Cancer AJCC v6 and v7 Stage I Breast Cancer AJCC v7 Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage II Breast Cancer AJCC v6 and v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Radiation: Accelerated Partial Breast Irradiation Radiation: Proton Beam Radiation Therapy Other: Quality-of-Life Assessment Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the cosmesis, acute toxicity and late toxicity in patients treated with accelerated partial breast irradiation delivered with proton radiation.

SECONDARY OBJECTIVES:

I. To evaluate the convenience of accelerated partial breast irradiation and quality of life during accelerated partial breast irradiation.

II. To estimate the in-breast tumor control rates in patients treated with accelerated partial breast irradiation delivered with proton radiation.

III. Compare dosimetry to alternate treatment modalities.

OUTLINE:

Within 10 weeks of last breast cancer surgery, patients undergo accelerated partial breast irradiation (APBI) delivered with proton radiation twice daily (BID) for 5 days.

After completion of study treatment, patients are followed up at 6 weeks, 6 months, 1 year, and 18 months, then annually for 10 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing the Cosmesis and Toxicity of Partial Breast Irradiation Using Proton Beam Irradiation
Actual Study Start Date : November 15, 2010
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Treatment (APBI)
Within 10 weeks of last breast cancer surgery, patients undergo APBI delivered with proton radiation BID for 5 days.
Radiation: Accelerated Partial Breast Irradiation
Undergo APBI delivered with proton radiation
Other Name: APBI

Radiation: Proton Beam Radiation Therapy
Undergo APBI delivered with proton radiation
Other Names:
  • PBRT
  • Proton Radiation Therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment




Primary Outcome Measures :
  1. Patient-Reported Cosmesis Score [ Time Frame: 1 year ]
    Patient-reported cosmesis score on the Breast Cancer Treatment Outcomes Scale (BCTOS) at 1 year. Cosmesis scores range from 1 (excellent) to 4 (poor), and scores of 3 (fair) or more indicate adverse cosmetic outcomes.


Secondary Outcome Measures :
  1. Rate of CTCAE Grade 3+ Confluent Moist Desquamation [ Time Frame: Within 6 weeks of radiation therapy ]
    Rate of CTCAE grade 3+ confluent moist desquamation estimated within 6 weeks of radiation therapy with a 90% credible interval. If we observe CTCAE grade 3+ confluent moist desquamation in only 20 patients, then our 90% credible interval will be 7% to 13%.

  2. Percent of Patients with Local Failure [ Time Frame: 10 years ]
    Percent of patients with local failure at 10 years estimated with an exact 95% confidence interval. If there is 1 patient with local failure at 10 years, and researchers have follow-up on all patients at 10 years, then the upper limit of the exact 95% confidence interval will be 2.8%. If researchers don't have 10 years of follow-up on all patients researchers will use the product-limit estimator of Kaplan and Meier (1958) to estimate the local failure rate at 10 years.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines
  • The patient must have stage 0, I, or II breast cancer; if stage II, the tumor size must be 3 cm or less
  • On histological examination, the tumor must be ductal carcinoma in situ (DCIS) or invasive adenocarcinoma of the breast
  • Surgical treatment of the breast must have been lumpectomy; the margins of the resected specimen must be histologically free of tumor (DCIS and invasive); reexcision of surgical margins is permitted
  • Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm or less; (patients with microscopic multifocality are eligible as long as total pathologic tumor size is 3 cm or less)
  • Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes); axillary staging is not required for patients with DCIS
  • The target lumpectomy cavity must be clearly delineated and the target lumpectomy cavity/whole breast reference volume must be less than or equal to 30% based on the postoperative/pre-enrollment computed tomography (CT) scan
  • Patients are eligible if, based on the postoperative CT scan, partial breast irradiation (PBI) is judged to be technically deliverable
  • Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to enrollment and are deemed by their physician to be at low risk for recurrence; patients with the following cancers are eligible if diagnosed and treated within the past 5 years; carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin

Exclusion Criteria:

  • Men are not eligible for this study
  • T2 (> 3.0 cm), T3, stage III, or stage IV breast cancer
  • More than 3 histologically positive axillary nodes
  • Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension
  • Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes at time of enrollment unless there is histologic confirmation that these nodes are negative for tumor
  • Suspicious microcalcifications, or densities (in the ipsilateral or contralateral breast as documented on mammogram or breast ultrasound) unless biopsied and found to be benign
  • Non-epithelial breast malignancies such as sarcoma or lymphoma
  • Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters
  • Paget's disease of the nipple
  • Synchronous bilateral invasive or non-invasive breast cancer
  • Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation; (if surgical margins are rendered free of disease by reexcision, the patient is eligible)
  • Clear delineation of the extent of the target lumpectomy cavity not possible
  • Treatment plan that includes regional nodal irradiation
  • Prior radiation to the index breast
  • Documented diagnosis of collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma
  • Pregnancy or lactation at enrollment
  • Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01245712


Contacts
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Contact: Eric A. Strom, BS,MD 713-563-2300 estrom@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Eric A. Strom    713-563-2300    estrom@mdanderson.org   
Principal Investigator: Eric A. Strom         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Eric A Strom M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01245712    
Other Study ID Numbers: 2009-0818
NCI-2011-01102 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2009-0818 ( Other Identifier: M D Anderson Cancer Center )
First Posted: November 22, 2010    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal, Breast
Breast Carcinoma In Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Adenocarcinoma
Carcinoma, Ductal
Neoplasms, Ductal, Lobular, and Medullary