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New combo therapy aims to save more breasts in High-Risk cancer

NCT ID NCT02806258

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding a short course of focused radiation to standard chemotherapy before surgery could improve outcomes for women with aggressive breast cancers. The trial enrolled 362 patients with luminal B or triple-negative breast cancer that was too large for initial breast-conserving surgery. Participants received either chemotherapy alone or chemotherapy plus accelerated partial breast irradiation, followed by surgery. The study was terminated early, so the full impact on complete response rates and breast conservation remains uncertain.

What this could mean

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

Active substance
chemotherapy (anthracycline and/or taxane based) and accelerated partial breast irradiation
What this could lead to
If successful, this approach could increase the chance of a complete response and allow more women to have breast-conserving surgery instead of mastectomy.
What could go wrong
The trial was terminated early, so results are limited. Adding radiation before surgery may increase side effects without clear benefit.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 362 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2016

Finished

May 2025

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 years and older

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: * Patients ≥ 18 years of age * Histologically confirmed invasive carcinoma of the breast * Patient who desires breast conservation * Tumor stage T1N1, T2-3 N0-1 * Operable BC for which an indication for CT is determined, including T1N1 and high risk T2-3 N0-1 tumors. * Lobular and/or ductal invasive carcinoma * Confirmation by imaging (standard +/- MRI) of unicentric and unilateral disease * Luminal B (defined by hormone receptor positive and grade II-III (if available from core biopsy) and Ki67 ≥ 15% or by genomic analysis) and TNG subtypes * HER2 negative * No distant metastases * No contraindication for PST with anthracycline and/or taxane based regimens * Patients with no psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator with the aid of written information. Exclusion Criteria: * Patients considered too frail for CT whatever their age. * Breast cancer clinical grade T4 and /or with major nodal involvement N2 (clinically, US, MRI or PET-CT). * Lumpectomy is considered to be possible with an anticipated favourable cosmetic outcome considering the tumor size/breast size * Multicentricity that would not allow BCS as confirmed by breast imaging * Uni or bilateral inflammatory (T4d) BC * Metastatic disease * Other histology types: ciribriform or tubular or mucinous or epideroid carcinomas * Her2 positive * No signed consent to participate in the study * Previous malignancy (except non melanoma skin cancer, thyroid carcinoma, non-invasive cancers outside the breast and patients with previous cancer in remission since more \> 5 years) * Patients with psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule * Patients unwilling or unable to comply with the protocol (especially necessity to undergo breast surgery despite clinical complete response) * Patients who have received any other investigational drugs within 30 days prior to the screening visit * Pregnancy * Active connective tissue disease involving the skin * Patients with other concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study .

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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

  • AP-HP Henri mondor

    Paris, France

  • CHI Créteil

    Créteil, France

  • CHU Avicenne

    Paris, France

  • CHU de Grenoble

    Grenoble, 38043, France

  • H. Hartmann Institute of Radiotherapy and Radiosurgery

    Paris, France

  • Tenon hospital

    Paris, France

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