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Estrogen Receptor-positive Breast CancerNCT02186470

Intensity Modulated Accelerated Partial Breast Irradiation Before Surgery in Treating Older Patients With Hormone Responsive Stage 0-I Breast Cancer

A study testing accelerated partial breast irradiation, intensity-modulated radiation therapy and image-guided radiation therapy in people with Estrogen Receptor-positive Breast Cancer and Invasive Ductal Breast Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot clinical trial studies intensity-modulated accelerated partial breast irradiation (APBI) before surgery in treating older patients with estrogen receptor positive or progesterone receptor positive stage I breast cancer. Read more about this study

Who is it for?
Ages 50 years and older, women only
What is being tested?
accelerated partial breast irradiation, intensity-modulated radiation therapy and image-guided radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
29 Apr 2016to 4 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines.
  • Patient must be ≥ 50 years
  • Core biopsy demonstrating breast cancer and receptors that are ER or PR positive.
  • Core tissue must have HER 2 negative followed by current ASCO/CAP guidelines.
  • The patient must have clinical node negative, stage I breast cancer.
  • The surgical treatment must be intended to be a lumpectomy
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  • The biopsy site must have been demarcated by a clip(s)
  • Gross disease must be unifocal on Mammo/ MRI imaging
  • Patients must have estrogen receptor (ER) and progesterone receptor (PR) analysis performed on core biopsy
  • Patient must be able to tolerate lying in the prone position with arms extended forward.
  • Must be able to tolerate MRI scan with contrast
  • At the time of enrollment, patients must have had bilateral mammograms within 6 months.
  • Patients must be willing to undergo breast cancer surgery minimally 4, maximally 6 weeks post APBI.
  • 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 physicians 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

  • Age < 50 years
  • Hormone unresponsive breast cancer
  • T-2 ( > 3.0 cm), T-3, Stage III, or Stage IV breast cancer.
  • N-1, N-2, or N-3 clinical axillary nodes
  • Mastectomy intended
  • Unwilling to undergo anti-endocrine therapy
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  • Suspicious microcalcification, densities, or palpable abnormalities ( in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
  • Non-epithelial breast malignancies such as sarcoma or lymphoma.
  • Paget's disease of the nipple
  • Proven multicentric carcinoma (invasive or DCIS) in more than one quadrant or separated by > 4 centimeters.
  • Any prior treatment with radiation therapy, chemotherapy, biotherapy, or hormone therapy for the currently diagnosed breast cancer prior to study enrollment.
  • Prior breast or thoracic RT for any condition.
  • Psychiatric of addictive disorders or other condition that in the opinion of the investigator would preclude the patient from meeting the study requirements.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Feasibility of Assessing Radiation Response With MRI/CT Directed Preoperative Accelerated Partial Breast Irradiation in the Prone Position for Hormone Responsive Early Stage Breast Cancer

This pilot clinical trial studies intensity-modulated accelerated partial breast irradiation (APBI) before surgery in treating older patients with estrogen receptor positive or progesterone receptor positive stage I breast cancer. APBI is a specialized type of 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. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Read the detailed description

PRIMARY OBJECTIVES:

Establish the feasibility for preoperative APBI delivered with IMRT in the prone position using daily CT guidance for Stage I breast cancer patients who are intended to undergo a lumpectomy for breast conserving therapy.

SECONDARY OBJECTIVES:

  1. To determine the acute and late surgical and radiation toxicity of preoperative APBI delivered with IMRT in the prone position.
  2. To document the cosmetic appearance of the breast when treated with preoperative APBI IMRT in the prone position.
  3. Establish the percentage of patients that can meet dosimetric goals and normal tissue constraints if treated with preoperative APBI IMRT in the prone position.
  4. Evaluate molecular changes in breast cancer and/or stroma before and after preoperative APBI

OUTLINE:

Patients undergo image-guided intensity-modulated APBI twice daily (BID) in the prone position over a period of 5-10 days for a total of 10 treatment. Within 4-6 weeks post-APBI, patients undergo lumpectomy.

After completion of treatment, patients are followed up at 4 weeks and then every 6 months for 5 years.

Being tested
accelerated partial breast irradiation, intensity-modulated radiation therapy, image-guided radiation therapy, therapeutic conventional surgery
Keywords
Breast Cancer, Early Stage Breast Cancer, Hormone responsive breast cancer
Medical subject headings
Carcinoma, Ductal, Breast, 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 image-guided intensity-modulated APBI

  • intensity-modulated radiation therapyRadiation

    Also called IMRT

    Undergo image-guided intensity-modulated APBI

  • image-guided radiation therapyRadiation

    Undergo image-guided intensity-modulated APBI

  • therapeutic conventional surgeryProcedure or surgery

    Lumpectomy

Study groups in NCT02186470
Study groupRoleWhat they receive
Treatment (image-guided intensity-modulated APBI)ExperimentalPatients undergo image-guided intensity-modulated APBI twice daily (BID) in the prone position over a period of 5-10 days for a total of 10 treatment. Within 4-6 weeks post-APBI, patients undergo lumpectomy.
Receives: Radiation: accelerated partial breast irradiation; Radiation: intensity-modulated radiation therapy; Radiation: image-guided radiation therapy; Procedure: therapeutic conventional surgery

What is being measured

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

  1. The primary endpoint will be the reproducibility of the MRI directed preoperative APBI treatment method

    Acceptability of the definition of treatment targets by MRI, radiation virtual IMRT plans and completion of treatment (APBI and surgery).

    Measured: 4-6 weeks post-APBI

Secondary outcomes (10)

  1. Acute surgical and radiotherapy toxicity as scored by the National Cancer Institute Common Toxicity Criteria (NCI CTCAE) version 4.0

    Measured: Up to 4 weeks post-surgery

  2. Late surgical and radiotherapy toxicity as scored by the NCI CTCAE version 4.0

    Measured: Up to 5 years

  3. Cosmetic outcome by the physician and patient

    Measured: At year 1

  4. Cosmetic outcome by the physician and patient

    Measured: At year 3

  5. In-breast recurrence

    Measured: Up to 5 years

  6. Regional recurrence

    Measured: Up to 5 years

  7. Distant metastases

    Measured: Up to 5 years

  8. Disease free survival

    Measured: Up to 5 years

  9. Overall survival

    Measured: Up to 5 years

  10. Exploratory evaluation of patient breast cancer tissue and serum for CSCs, biomarkers and miRNAs

    Correlative analyses

    Measured: Up to 4 weeks post-surgery

Timeline

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

  1. First posted10 Jul 2014 (estimated)
  2. Study start29 Apr 2016
  3. Primary completion4 Sep 2025
  4. Study completion4 Sep 2025

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02186470
Sponsor's protocol ID
OSU-13282
Other IDs
NCI-2014-01248
Status last verified
Sep 2025
First submitted
7 Jul 2014
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing accelerated partial breast irradiation, intensity-modulated radiation therapy and image-guided radiation therapy in people with Estrogen Receptor-positive Breast Cancer and Invasive Ductal Breast Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site 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?

The sponsor lists 14 inclusion and 13 exclusion criteria. 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: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The primary endpoint will be the reproducibility of the MRI directed preoperative APBI treatment method (time frame: 4-6 weeks post-APBI). 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 NCT02186470.

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 22 Sep 2025.

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