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New study tests if Same-Time radiation and chemo is safe for breast cancer

NCT ID NCT01928589

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at women with early-stage breast cancer who need both radiation and chemotherapy after surgery. It compares giving these treatments at the same time versus one after the other, to see if the combined approach has similar side effects and outcomes. About 81 women will take part, with most receiving the new same-time method.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
partial breast irradiation and chemotherapy
What this could lead to
If successful, this could offer a more convenient treatment schedule for early-stage breast cancer patients, potentially reducing the time needed for therapy.
What could go wrong
This is a small, early-phase study (81 participants) comparing two approaches, so results may not apply broadly. There is a risk of increased side effects when combining treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

81 people

The number who actually took part.

Started

Jan 2014

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Age ≥ 18 years. Patient must have histologically confirmed (by routine H\&E staining) invasive adenocarcinoma of the breast. Primary tumor ≤ 4cm and 0-3 positive axillary lymph nodes (T1-2, N0-1, M0). Margin negative surgery. For subjects with two breasts, they must have had a bilateral mammogram prior to surgery. Patient must have a Medical Oncology consult with the recommendation of chemotherapy. Recommended regimens are as follows: Cyclophosphamide and Doxorubicin (AC); Taxotere, Doxorubicin and Cyclophosphamide (TAC); Taxotere and Cyclophosphamide (TC); or Taxotere, Carboplatin withTrastuzamab (TCH) prior to registration; or Paclitaxel and Trastuzumab. The use of additional chemotherapy, hormonal therapy or Trastuzumab after the initial regimen is at the discretion of the Medical Oncologist. Other primary regimens are possible but the PI must be notified prior to enrollment. Partial breast irradiation must be scheduled to begin less than 71 days from the last breast surgical procedure. ECOG performance status ≤ 1. Women of child-bearing potential must have a negative (urine or blood) pregnancy test within 6 weeks prior to start of protocol therapy. Women of childbearing potential must also use effective non-hormonal contraception while undergoing radiation treatment and chemotherapy. Note: Women over the age of 70 will not be considered as having child-bearing potential for this study. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria Patients who have received neoadjuvant chemotherapy or neoadjuvant hormonal therapy for the current cancer. Patients with squamous cell cancer or sarcomas of the breast. Patients who have active local-regional disease prior to registration. Patient with a prior ipsilateral breast cancer (invasive or non-invasive) from which the patient has been disease free for less than 5 years. Patient is pregnant. Patient has a serious medical or psychiatric illness which prevents informed consent or adherence with treatment. Study team (PI, Co-I, and or research nurse) may deny enrollment if in the study team's opinion, the candidate may not be adherent to the treatment protocol including scheduled follow-ups.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • IU Health Arnett

    Lafayette, Indiana, 47905, United States

  • Indiana University Health Hospital

    Indianapolis, Indiana, 46202, United States

  • Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202, United States

  • John Hopkins University

    Baltimore, Maryland, 21218, United States

  • Parkview Regional Medical Center

    Fort Wayne, Indiana, 46845, United States

  • Reading Hospital

    West Reading, Pennsylvania, 19611, United States

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016, United States

  • Suburban Hospital

    Bethesda, Maryland, 20814, United States

  • University of Texas-San Antonio

    San Antonio, Texas, 78229, United States

  • York Cancer Center

    York, Pennsylvania, 17403, United States

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