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Breast AdenocarcinomaPhase 2NCT01245712

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

A Phase 2 study testing Accelerated Partial Breast Irradiation, Proton Beam Radiation Therapy and Quality-of-Life Assessment in people with Breast Adenocarcinoma and Ductal Breast Carcinoma In Situ, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Accelerated Partial Breast Irradiation, Proton Beam Radiation Therapy and Quality-of-Life Assessment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
15 Nov 2010to 31 Dec 2032
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women who satisfy all of the following conditions are the only patients who will be eligible for this study.
  • The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines.
  • Patients must be >/= 18 years old. (Adenocarcinoma of the breast is not seen in children)
  • English and non-English speaking patient
  • 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 DCIS or invasive adenocarcinoma of the breast.
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  • Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (DCIS and invasive).
  • Re-excision 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 < 30% based on the postoperative/pre-enrollment CT scan.
  • Patients are eligible if, based on the postoperative CT scan, 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.

Who cannot join

  • Women with one or more of the following conditions also are ineligible for this study.
  • Men are not eligible for this study.
  • Individuals that are considered to be cognitively impaired.
  • 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.
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  • 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 re-excision, 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 CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
  • Pregnancy or lactation at enrollment.
  • Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Assessing the Cosmesis and Toxicity of Partial Breast Irradiation Using Proton Beam Irradiation

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.

Read the detailed description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

  1. 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.

Being tested
Accelerated Partial Breast Irradiation, Proton Beam Radiation Therapy, Quality-of-Life Assessment
Medical subject headings
Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Accelerated Partial Breast IrradiationRadiation

    Also called APBI

    Undergo APBI delivered with proton radiation

  • Proton Beam Radiation TherapyRadiation

    Also called PBRT, Proton Radiation Therapy

    Undergo APBI delivered with proton radiation

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT01245712
Study groupRoleWhat they receive
Treatment (APBI)ExperimentalWithin 10 weeks of last breast cancer surgery, patients undergo APBI delivered with proton radiation BID for 5 days.
Receives: Radiation: Accelerated Partial Breast Irradiation; Radiation: Proton Beam Radiation Therapy; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient-Reported Cosmesis Score

    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.

    Measured: 1 year

Secondary outcomes (2)

  1. Rate of CTCAE Grade 3+ Confluent Moist Desquamation

    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%.

    Measured: Within 6 weeks of radiation therapy

  2. Percent of Patients with Local Failure

    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.

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2010 (estimated)
  2. Study start15 Nov 2010
  3. Primary completion31 Dec 2032 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01245712
Sponsor's protocol ID
2009-0818
Other IDs
NCI-2011-01102, 2009-0818
Status last verified
Apr 2026
First submitted
19 Nov 2010
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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