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Could a lower starting dose help older breast cancer patients stick with treatment?

NCT ID NCT06377852

Knowledge-focused Sponsor: American Society of Clinical Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 3 times

Summary

This study looks at whether starting with a lower dose of CDK4/6 inhibitor pills (palbociclib or ribociclib) and gradually increasing the dose helps older adults (age 65+) with metastatic breast cancer tolerate side effects better and stay on treatment longer. About 500 participants will be randomly assigned to either the standard approved dose or a lower starting dose that can be increased if well-tolerated. The goal is to find a dosing strategy that reduces treatment discontinuation while maintaining effectiveness.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 500 people

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

Started

Oct 2024

Expected to finish

Sep 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

60 years and older

Sex

Anyone

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: 1. Hormone receptor positive (HR+) HER2 negative metastatic breast cancer. Cut-off values for positive/negative staining should be as per standard practice in accordance with ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines. Verification of histology is preferred at the time of recurrence and where not possible or necessary in the judgment of the treating physician, the study will accept histology from the initial diagnosis. 2. Candidate for planned endocrine therapy in combination with 1st use of palbociclib or ribociclib, in the metastatic setting. The planned endocrine partner can be an aromatase inhibitor (letrozole, anastrozole, exemestane) or fulvestrant, selected through patient/provider choice. 3. Aged 60 years or older 4. Adequate bone marrow and organ function. Laboratory values must be within normal institutional limits, or within ranges as indicated below, or demonstrate minor abnormalities that are deemed clinically non-significant by the investigator. * Absolute neutrophil count ≥ 1,000/µL * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (participants with documented Gilbert's disease are allowed total bilirubin up to 5X ULN) * AST (SGOT)/ALT (SGPT) \<3 x institutional ULN, or ≤ 5 x ULN for subjects with documented metastatic disease to the liver. 5. Baseline QTc ≤ 480 ms (only for ribociclib patients) 6. Ability to understand and the willingness to provide informed consent. Note: Remote consent is allowed per institutional guidelines. Exclusion Criteria: 1. Previous treatment with a CDK4/6 inhibitor for metastatic breast cancer, or previous treatment within the past 12 months with a CDK4/6 inhibitor in the neo/adjuvant breast cancer setting. 2. Received greater than 60 days (in the metastatic setting) of the specific endocrine therapy agent planned as partner to the CDK4/6 inhibitor in the study at the time of randomization. 3. Known history of intolerance or allergy to the planned agents used in this trial. 4. Uncontrolled intercurrent illness that, as evaluated by the treating clinician, would hinder compliance with study requirements. 5. Concurrent therapy with other investigational agents or anticancer therapy beyond aromatase inhibitors or fulvestrant. Note: radiation is allowed at any time. 6. Rapidly progressive brain metastases. Note: only applies to patients with known brain metastases. Brain imaging not required for enrollment. 7. Active or chronic Hepatitis B or C are eligible provided they meet liver function laboratory criteria and are not on medication with a known interaction with the study agents. 8. Current use of drugs that have known potential to prolong the QT interval (e.g., antiarrhythmic drugs), for patients on ribociclib. Note: If concomitant use cannot be avoided, monitor ECG when initiating, during concomitant use, and as clinically indicated. Refer to crediblemeds.org as a resource. 9. Prior or concurrent malignancies that are undergoing active treatment.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Metastatic breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    73 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Baptist Memorial Healthcare

    RECRUITING

    Memphis, Tennessee, 38120, United States

  • Dana-Farber Brigham Cancer Center Foxborough

    RECRUITING

    Foxborough, Massachusetts, 02035, United States

  • Dana-Farber Brigham Cancer Center at Milford Regional Medical Center

    RECRUITING

    Milford, Massachusetts, 01757, United States

  • Dana-Farber Brigham Cancer Center at South Shore Health

    RECRUITING

    Weymouth, Massachusetts, 02190, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Dana-Farber Cancer Institute Merrimack Valley

    RECRUITING

    Methuen, Massachusetts, 01844, United States

  • Dana-Farber/New Hampshire Oncology-Hematology

    RECRUITING

    Londonderry, New Hampshire, 03053, United States

  • Emory University Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Ironwood Cancer & Research Centers

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Ironwood Cancer & Research Centers

    RECRUITING

    Gilbert, Arizona, 85297, United States

  • Ironwood Cancer & Research Centers

    RECRUITING

    Glendale, Arizona, 85306, United States

  • Ironwood Cancer & Research Centers

    RECRUITING

    Goodyear, Arizona, 85395, United States

  • Ironwood Cancer & Research Centers

    RECRUITING

    Mesa, Arizona, 85202, United States

  • Ironwood Cancer & Research Centers

    RECRUITING

    Mesa, Arizona, 85206, United States

  • Ironwood Cancer & Research Centers

    RECRUITING

    Phoenix, Arizona, 85028, United States

  • Ironwood Cancer & Research Centers

    RECRUITING

    Scottsdale, Arizona, 85260, United States

  • Levine Cancer Institute

    RECRUITING

    Albemarle, North Carolina, 28001, United States

  • Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28210, United States

  • Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28211, United States

  • Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28262, United States

  • Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28277, United States

  • Levine Cancer Institute

    RECRUITING

    Concord, North Carolina, 28025, United States

  • Levine Cancer Institute

    RECRUITING

    Forest City, North Carolina, 28043, United States

  • Levine Cancer Institute

    RECRUITING

    Gastonia, North Carolina, 28054, United States

  • Levine Cancer Institute

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • Levine Cancer Institute

    RECRUITING

    Lincolnton, North Carolina, 28092, United States

  • Levine Cancer Institute

    RECRUITING

    Matthews, North Carolina, 28104, United States

  • Levine Cancer Institute

    RECRUITING

    Monroe, North Carolina, 28112, United States

  • Levine Cancer Institute

    RECRUITING

    Shelby, North Carolina, 28150, United States

  • Levine Cancer Institute

    RECRUITING

    Rock Hill, South Carolina, 29732, United States

  • Lewis Cancer and Research Pavilion

    RECRUITING

    Savannah, Georgia, 31405, United States

  • Lovelace Medical Center - Saint Joseph Square

    RECRUITING

    Albuquerque, New Mexico, 87102, United States

  • Lovelace Women's Hospital

    RECRUITING

    Albuquerque, New Mexico, 87109, United States

  • Memorial Medical Center

    RECRUITING

    Las Cruces, New Mexico, 88011, United States

  • Miami Cancer Institute

    RECRUITING

    Miami, Florida, 33176, United States

  • Miami Cancer Institute

    RECRUITING

    Plantation, Florida, 33324, United States

  • Northwest Medical Specialties

    RECRUITING

    Bonney Lake, Washington, 98391, United States

  • Northwest Medical Specialties

    RECRUITING

    Federal Way, Washington, 98003, United States

  • Northwest Medical Specialties

    RECRUITING

    Gig Harbor, Washington, 98332, United States

  • Northwest Medical Specialties

    RECRUITING

    Olympia, Washington, 98502, United States

  • Northwest Medical Specialties

    RECRUITING

    Puyallup, Washington, 98373, United States

  • Northwest Medical Specialties

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Penn Medicine - Chester County Hospital

    RECRUITING

    West Chester, Pennsylvania, 19380, United States

  • Penn Medicine - Lancaster General Hospital

    RECRUITING

    Lancaster, Pennsylvania, 17601, United States

  • Penn Medicine - Pennsylvania Hospital

    RECRUITING

    Philidelphia, Pennsylvania, 19106, United States

  • Penn Medicine - Perelman Center for Advanced Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Penn Medicine - Princeton Health

    RECRUITING

    Plainsboro, New Jersey, 08536, United States

  • Presbyterian Kaseman Hospital

    RECRUITING

    Albuquerque, New Mexico, 87110, United States

  • Presbyterian Rust Medical Center/Jorgensen Cancer Center

    RECRUITING

    Rio Rancho, New Mexico, 87124, United States

  • SC Cancer Specialists - Hilton Head at St. Joseph's/Candler

    RECRUITING

    Hilton Head Island, South Carolina, 29926, United States

  • Smilow Cancer Hospital - Waterford

    RECRUITING

    Waterford, Connecticut, 06385, United States

  • Smilow Cancer Hospital - Westerly

    RECRUITING

    Westerly, Rhode Island, 02891, United States

  • Smilow Cancer Hospital - Yale New Haven Health

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • Smilow Cancer Hospital Care Center - Derby

    RECRUITING

    Derby, Connecticut, 06418, United States

  • Smilow Cancer Hospital Care Center - Fairfield

    RECRUITING

    Fairfield, Connecticut, 06824, United States

  • Smilow Cancer Hospital Care Center - Greenwich

    RECRUITING

    Greenwich, Connecticut, 06830, United States

  • Smilow Cancer Hospital Care Center - Guilford

    RECRUITING

    Guilford, Connecticut, 06437, United States

  • Smilow Cancer Hospital Care Center - North Haven

    RECRUITING

    North Haven, Connecticut, 06473, United States

  • Smilow Cancer Hospital Care Center - Torrington

    RECRUITING

    Torrington, Connecticut, 06790, United States

  • Smilow Cancer Hospital Care Center - Trumbull

    RECRUITING

    Trumbull, Connecticut, 06611, United States

  • Smilow Cancer Hospital Care Center - Waterbury

    RECRUITING

    Waterbury, Connecticut, 06708, United States

  • Smilow Cancer Hospital at Glastonbury

    RECRUITING

    Glastonbury, Connecticut, 06033, United States

  • Smilow Cancer Hospital at Saint Francis

    RECRUITING

    Hartford, Connecticut, 06105, United States

  • St. Joseph's Candler Bluffton Campus

    RECRUITING

    Bluffton, South Carolina, 29910, United States

  • The Jackson Laboratory (JAX) - Harold Alfond Center for Cancer Care

    RECRUITING

    Augusta, Maine, 04330, United States

  • The Jackson Laboratory (JAX) - Northern Light Cancer Care

    RECRUITING

    Brewer, Maine, 04412, United States

  • The University of Kansas Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • The University of New Mexico Comprehensive Cancer Center

    RECRUITING

    Albuquerque, New Mexico, 87131, United States

  • UCHealth Cherry Creek Medical Center

    RECRUITING

    Denver, Colorado, 80206, United States

  • UCHealth Highlands Ranch Hospital

    RECRUITING

    Highlands Ranch, Colorado, 80129, United States

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Yale University/Yale Cancer Center/Yale School of Medicine

    RECRUITING

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.