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Genetic clues may reveal why some breast cancers resist treatment

NCT ID NCT03439735

Knowledge-focused Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This study is investigating whether genetic changes in tumor tissue and blood can predict how well people with hormone receptor-positive metastatic breast cancer respond to a combination of endocrine therapy and palbociclib. Researchers will collect tumor samples and blood from participants over time to look for specific mutations, like ESR1, that may be linked to treatment resistance. The goal is to better understand why some cancers stop responding, which could help tailor future treatments for each person.

What this could mean

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

Active substance
Endocrine therapy and palbociclib (a CDK4/6 inhibitor)
What this could lead to
If successful, this could help doctors personalize treatment for metastatic breast cancer, identifying who will benefit from endocrine therapy and palbociclib and who might need different options.
What could go wrong
This is a small, early-stage study focused on understanding resistance, not on proving a new treatment works. The genetic markers studied may not reliably predict response, and results may not apply to all patients.

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

45 people

The number who actually took part.

Started

Jul 2018

Expected to finish

Nov 2027

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

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: * Male or Female * 18 years or older * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Metastatic (stage IV) breast cancer or locally advanced breast cancer * Estrogen Receptor (ER) and/or Progesterone Receptor (PR) positive, HER2- negative * Treatment naïve in metastatic or locally advanced setting and planning to undergo treatment with endocrine therapy (ET) and palbociclib OR receiving first-line ET and palbociclib for metastatic or locally advanced disease. * Premenopausal women and men must be treated with concurrent luteinizing hormone-releasing hormone (LHRH) agonist as would be standard-of-care. * Evaluable or measurable disease. * Tissue from a metastatic site must be available within past 6 months prior to therapy initiation. * Ability to give voluntary informed consent Exclusion Criteria: * Any pregnant or nursing woman * No history of another primary malignancy within past 5 years. Patients with prior history of in situ cancer or basal or localized squamous cell skin cancer are eligible.

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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

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

More trials for these conditions

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