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AzTrials

Breast CancerPhase 2NCT00909909

Radiation Therapy in Treating Women With Early Stage Breast Cancer

A Phase 2 study testing External beam boost and whole breast irradiation in people with Breast Cancer, run by Rutgers, The State University of New Jersey at 4 sites 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

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. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
External beam boost and whole breast irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
4 sitesUnited States
Study dates
13 May 2009to Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • RWJBarnabas Health - Robert Wood Johnson University Hospital

    Hamilton, New Jersey, 08690

  • RWJBarnabas Health - Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08690

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • RWJBarnabas Health - Robert Wood Johnson University Hospital

    Somerset, New Jersey, 08873

Other trials in United States

About this study

Official title: Safety and Feasibility of Accelerated, Hypofractionated Radiotherapy in Women With Breast Cancer: A Phase II Trial

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.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the freedom from local and regional failure in women with early stage breast cancer treated with accelerated, hypofractionated radiotherapy.
  • To determine the acute and late toxicity of accelerated, hypofractionated radiotherapy using previously published toxicity scales.

Secondary

  • To measure cosmesis using the Harvard cosmesis scale in patients who have undergone lumpectomy.
  • To identify co-variates responsible for poor cosmetic outcome in these patients.

OUTLINE: Patients who have undergone lumpectomy undergo either intracavitary balloon brachytherapy boost and hypofractionated, accelerated whole breast irradiation (AWBI) OR 3D-conformal radiotherapy (3D-CRT)/intensity-modulated radiotherapy (IMRT) boost and AWBI. Patients who have undergone mastectomy undergo hypofractionated, accelerated chest wall irradiation.

  • Intracavitary balloon brachytherapy boost and AWBI (post-lumpectomy): Patients undergo intracavitary balloon brachytherapy boost twice daily for 2 days (total of 4 fractions). Beginning 5-21 days after completion of brachytherapy, patients undergo AWBI once daily 5 days a week for approximately 2 weeks (total of 11 fractions).
  • 3D-CRT/IMRT boost and AWBI (post-lumpectomy): Patients undergo 3D-CRT/IMRT boost twice daily for 2 days (total of 4 fractions). Patients also undergo AWBI as above before or after boost radiotherapy.
  • Accelerated chest wall irradiation (post-mastectomy): Patients undergo accelerated chest wall irradiation once daily 5 days a week for approximately 2 weeks (total of 11 fractions).

Patients who have undergone lumpectomy undergo frontal digital photography of the breasts at baseline, immediately before the initiation of radiotherapy, and then annually for 3 years after completion of radiotherapy. These patients also complete the Breast Cancer Treatment Outcome Scale at baseline and at 3 years after completion of radiotherapy. Physicians complete the Harvard Cosmesis scale at baseline and at 1 and 3 years after completion of radiotherapy.

After completion of study treatment, patients are followed up at weeks 1, 4, and 8 and then every 4 months for 2 years, every 6 months for 3 years, and annually thereafter.

Conditions
Breast Cancer
Being tested
External beam boost, whole breast irradiation
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
Medical subject headings
Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Ductal, Breast, Carcinoma, Lobular

What participants receive

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

  • External beam boostRadiation

    3-dimensional conformal radiation therapy and intensity modulated radiation therapy

  • whole breast irradiationRadiation

    accelerated, hypofractionated whole breast irradiation

Study groups in NCT00909909
Study groupRoleWhat they receive
AActive comparator3DCRT/IMRT lumpectomy bed boost followed by accelerated whole breast irradiation (AWBI)
Receives: Radiation: External beam boost; Radiation: whole breast irradiation
BActive comparatorAccelerated whole breast irradiation (AWBI) followed by 3DCRT/IMRT lumpectomy bed boost
Receives: Radiation: External beam boost; Radiation: whole breast irradiation

What is being measured

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

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

    Measured: 5 years

Secondary outcomes (2)
  1. Toxicity (including seroma formation, brachial plexopathy, fat necrosis, pain, pigmentation, and telangiectasia) as assessed by NCI CTCAE v3.0

    Measured: 5 years

  2. Cosmesis as assessed by the Breast Cancer Treatment Outcome Scale

    Measured: 5 years

Timeline

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

  1. First posted29 May 2009 (estimated)
  2. Study start13 May 2009
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00909909
Sponsor's protocol ID
Pro20170001671
Other IDs
CDR0000643276, P30CA072720, 0220090059, 040807
Status last verified
Aug 2023
First submitted
28 May 2009
Last updated
3 Aug 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 40836156
  • 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.

    PubMed 26700706

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing External beam boost and whole breast irradiation in people with Breast Cancer, run by Rutgers, The State University of New Jersey at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Loco-regional control as assessed by physical examination, mammography, and other relevant imaging (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00909909, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.

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