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Could a pill combo replace chemo for some breast cancers?

NCT ID NCT02712723

Disease control Sponsor: Qamar Khan Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether adding ribociclib to letrozole before surgery helps more women with ER-positive, HER2-negative early breast cancer achieve a low-risk score (PEPI 0) compared to letrozole alone. About 121 postmenopausal women with stage II or III breast cancer will take the drugs for 24 weeks before surgery. The goal is to see if this combo can improve outcomes and potentially spare patients from needing chemotherapy.

What this could mean

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

Active substance
Ribociclib (a targeted drug) combined with letrozole (a hormone therapy)
What this could lead to
If it works, this combination could help more women with early breast cancer avoid chemotherapy and still have a good outcome.
What could go wrong
This is a small, early-phase trial, so results may not apply to all patients. The drug combination can cause side effects like low blood cell counts or liver issues.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

121 people

The number who actually took part.

Started

Feb 2016

Expected to finish

Dec 2026

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 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.

Key Inclusion Criteria: * Pathologically confirmed invasive breast cancer by core needle biopsy * Female subjects, age ≥ 18 years * Only postmenopausal women will be eligible. * Performance Status: Eastern Cooperative Oncology Group (ECOG) score 0-2 * Invasive breast cancer must be ER+ in ≥66 % of the cells or ER Allred score 6-8 * Invasive breast cancer must be HER2 negative. * Clinical Stage II or III (by clinical measurement and/or breast imaging) Key Exclusion Criteria: * Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation. * Current use of other investigational agents * Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema) * An excisional biopsy of this breast cancer * Surgical axillary staging procedure prior to study entry * Hormone replacement therapy of any type, megestrol acetate, or raloxifene within four weeks prior to first study treatment * Clinical or radiographic evidence of metastatic disease * Clinically significant, uncontrolled heart disease * Herbal preparations/medications as listed in Appendix B of the protocol

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Cancer Research Collaboration

    Santa Ana, California, 92705, United States

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064, United States

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154, United States

  • University of Kansas Cancer Center - Overland Park

    Overland Park, Kansas, 66210, United States

  • University of Kansas Cancer Center - South

    Kansas City, Missouri, 64131, United States

  • University of Kansas Cancer Center - West

    Kansas City, Kansas, 66112, United States

  • University of Kansas Cancer Center - Westwood

    Westwood, Kansas, 66205, United States

  • University of Miami Sylvester Comprehensive Cancer Center

    Deerfield Beach, Florida, 33442, United States

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53705, United States

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