Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can an oral drug replace injections for advanced breast cancer?

NCT ID NCT03455270

NEW Disease control Sponsor: G1 Therapeutics, Inc. 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing a new oral drug called rintodestrant (G1T48) in women with advanced breast cancer that is estrogen receptor-positive and HER2-negative. The trial gives the drug alone or with palbociclib, a standard breast cancer medicine. The main goals are to find a safe dose and see how the body processes the drug. The study also looks at whether tumors respond.

What this could mean

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

Active substance
rintodestrant (G1T48), an oral selective estrogen receptor degrader, alone and with palbociclib
What this could lead to
If it works, this could offer an oral alternative to injected SERDs for advanced breast cancer and a new combination strategy with palbociclib.
What could go wrong
This is a small phase 1 trial, so the main goal is to find a safe dose. The drug may not shrink tumors, and combining it with palbociclib could add side effects.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

107 people

The number who actually took part.

Started

May 2018

Finished

Sep 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * For Part 1, postmenopausal women only * For Parts 2 and 3, any menopausal status * Confirmed diagnosis of ER-positive, HER2-negative advanced breast cancer, not amenable to curative therapy * For Part 1, prior treatment with less than 4 prior lines of chemotherapy * For Part 2, prior treatment with less than 2 prior line of chemotherapy * For Part 3, prior treatment with no more than 1 prior line of chemotherapy * For Parts 1 and 2, prior treatment with less than 4 prior endocrine therapies for metastatic breast cancer * For Part 3, prior treatment with no more than 1 prior line of endocrine therapies for metastatic breast cancer * For Parts 1 and 2, patients must satisfy 1 of the following criteria for prior therapy: * Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor * Progressed after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer * For Part 3, patients must satisfy 1 of the following criteria for prior therapy: * Received ≥ 24 months of endocrine therapy in the adjuvant setting prior to recurrence or progression * Received ≥ 6 months of endocrine therapy in the advanced/metastatic setting prior to progression * For Part 1, evaluable or measurable disease * For Parts 2 and 3, evaluable (approximately 25%) or measurable disease (approximately 75%) as defined by RECIST, Version 1.1 including bone-only disease * ECOG performance status 0 to 1 * Adequate organ function Exclusion Criteria: * For Part 3, prior treatment with CDK4/6 inhibitor, investigational oral SERDs or SERCAs in any setting * Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease * Anticancer therapy within 14 days of first G1T48 dose or within 28 days for antibody-based therapy * Concurrent radiotherapy, radiotherapy within 14 days of first G1T48 dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to \> 25% of bone marrow * Prior hematopoietic stem cell or bone marrow transplantation

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced breast cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

breast cancer breast ductal adenocarcinoma breast neoplasm female breast carcinoma hormone receptor-positive breast cancer

As listed by the trial registrant

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

Advanced breast cancer Breast cancer Breast cancer female Breast neoplasm Carcinoma, ductal, breast Metastatic breast cancer Stage IV breast cancer

Contacts and locations

Locations

  • ARENSIA Exploratory Medicine LLC

    Tbilisi, 0112, Georgia

  • ARENSIA Exploratory Medicine Phase I Unit, The Institute of Oncology

    Chisinau, 2025, Moldova

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211, United States

  • Erasmus Medical Center

    Rotterdam, 3015 GD, Netherlands

  • Institut Jules Bordet

    Brussels, 1000, Belgium

  • MHAT for Womens Health - Nadezhda OOD

    Sofia, 1330, Bulgaria

  • Northwestern University - Feinberg School of Medicine

    Chicago, Illinois, 60611, United States

  • Sarah Cannon Research Institute at Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Spizhenko Clinic

    Kiev, 08112, Ukraine

  • Stanford Women Cancer Center

    Stanford, California, 94305, United States

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • UZ Leuven

    Leuven, 3000, Belgium

  • University Medical Center Groningen

    Groningen, 9713 GZ, Netherlands

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7305, United States

  • VU University Medical Center

    Amsterdam, 1081 HV, Netherlands

More trials for these conditions

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