New study tests if Same-Time radiation and chemo is safe for breast cancer
NCT ID NCT01928589
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
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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
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81 people
The number who actually took part.
- Started
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Jan 2014
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 100 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
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IU Health Arnett
Lafayette, Indiana, 47905, United States
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Indiana University Health Hospital
Indianapolis, Indiana, 46202, United States
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Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
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John Hopkins University
Baltimore, Maryland, 21218, United States
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Parkview Regional Medical Center
Fort Wayne, Indiana, 46845, United States
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Reading Hospital
West Reading, Pennsylvania, 19611, United States
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Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
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Suburban Hospital
Bethesda, Maryland, 20814, United States
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University of Texas-San Antonio
San Antonio, Texas, 78229, United States
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York Cancer Center
York, Pennsylvania, 17403, United States
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