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New combo therapy aims to slow advanced breast cancer in BRCA patients

NCT ID NCT06201234

Disease control Sponsor: GBG Forschungs GmbH 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether adding elacestrant to the standard drug olaparib can help people with a certain type of advanced breast cancer (HR-positive, HER2-negative) that has a BRCA gene mutation. About 176 participants will be randomly assigned to receive either the combination or olaparib alone. The goal is to see if the combination delays cancer growth and improves quality of life.

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

About 176 people

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

Started

Dec 2024

Expected to finish

Dec 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

18 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: Patients will be eligible for study participation only if they comply with the following criteria: 1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for scheduled visit, the treatment and follow-up, must be obtained and documented according to the local regulatory requirements. 2. Female or male patients. 3. Age at study entry of at least 18 years. 4. Locally advanced or metastatic breast cancer that is HR-positive (ER and/or PgR ≥ 10% of stained cells at IHC) and HER2-negative (IHC 0 or 1+, or 2+ and ISH negative according to ASCO/CAP guidelines). 5. Patients with deleterious or suspected deleterious gBRCA1/2 mutation detected upon local testing. 6. Willingness and ability to provide archived formalin fixed paraffin embedded tissue (FFPE) block or a partial block from archived tumor or metastasis. 7. Indication for standard-of-care PARP inhibitor therapy and planned treatment with olaparib. 8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2. 9. Resolution of all acute toxic effects of prior anti-cancer therapy including endocrine therapy or surgical procedures to NCI CTCAE version 5.0 grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion). 10. Life-expectancy \> 6 months. 11. For female patients: patients of childbearing potential (defined as not post-menopausal and not permanently sterile \[latter defined as having undergone hysterectomy, bilateral salpingectomy, or bilateral oophorectomy\]) require a negative serum or urinary pregnancy test within 72 hours before starting treatment in this study (in this case, patients need to use highly effective non-hormonal contraceptive methods as specified in the protocol). For male patients: during the intervention period and for at least 120 days after the last dose of elacestrant, patients should refrain from heterosexual intercourse or use a condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak), and they should refrain from donating sperm. Exclusion Criteria: Patients will be ineligible for study participation if they fulfill any of the following criteria: 1. Known hypersensitivity reaction to one of the compounds, excipients, or substances used in this protocol. 2. Active or newly diagnosed CNS metastases, including leptomeningeal carcinomatosis, carcinomatous meningitis, or radiographic signs of CNS hemorrhage. Note: Patients with stable brain metastases are allowed. Radiotherapeutic treatment must be completed 1 week before planned day 1 of study therapy. 3. Presence of symptomatic metastatic visceral disease that are at risk of life-threatening complications in the short term, including but not confined to massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or fulminant liver involvement. 4. Inadequate organ function prior to enrolment including: * Hemoglobin \< 9 g/dL (\< 5.6 mmol/L) * Absolute neutrophil count (ANC) \< 1500/mm³ (\< 1.5 x 109/L) * Platelets \< 100,000/mm³ (\< 100 x 109/L) * Alanine aminotransferase (ALT/SGPT) and/or aspartate aminotransferase (AST/SGOT) \> 3 x upper normal limits (ULN). If the patient has liver metastases, ALT and AST should not be ≥ 5 x ULN. * Alkaline phosphatase (ALP) \> 2.5 x ULN * Total serum bilirubin \> 1.5 x ULN (exception: patients with Gilbert's syndrome permitted up to ≤ 3 x ULN) * Serum creatinine \> 1.5 x ULN or estimated creatinine clearance \< 50 mL/min as calculated using the standard method for the institution. 5. Existing contraindication against the use of the elacestrant or olaparib. 6. Prior treatment with PARP inhibitors. 7. Female patients: pregnancy or lactation at the time of randomization or intention to become pregnant during the study and for a predefined period after the end of treatment (as described in protocol). Male patients: intention to get a child during the study and for a predefined period after the end of treatment (as described in protocol). According to the treatment received during the study, required contraception timelines for female and male patients are described in the study protocol. 8. Any of the following within 6 months prior to enrolment: myocardial infarction, severe/unstable angina, ongoing grade ≥ 2 cardiac dysrhythmias, prolonged QT corrected by Fridericia's formula (QTcF) grade ≥ 2, uncontrolled atrial fibrillation of any grade, coronary/peripheral artery bypass graft, heart failure of New York Heart Association (NYHA) Class II or greater, or cerebrovascular accident including transient ischemic attack. 9. Uncontrolled hypertension at the time of screening (systolic BP \> 140 mmHg or diastolic BP \> 90 mmHg that has not been adequately treated or controlled). 10. Active and current anticoagulation for treatment purposes of thrombotic events occurring \< 6 months before enrolment is not allowed (prophylactic anticoagulation, however, is acceptable). Treatment with an anticoagulant for a thrombotic event occurring \> 6 months before enrolment, or for an otherwise stable and allowed medical condition (e.g., well controlled atrial fibrillation) is acceptable, provided dose and coagulation parameters (as defined by local standard of care) are stable for at least 28 days prior to the first dose of study drug. 11. Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications such as: uncontrolled nausea or vomiting (i.e., CTCAE ≥ grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction/motility disorder, malabsorption syndrome, or prior gastric bypass. 12. History of endometrial intraepithelial neoplasia in patients who have not undergone a hysterectomy. 13. Malignant disease other than breast cancer, active or being disease-free for less than 5 years (except carcinoma in situ of the cervix, DCIS, and non-melanomatous skin cancer adequately treated). 14. Uncontrolled significant active infections including HBV, HCV, and/or HIV. Patients with a positive hepatitis B surface antigen result or a positive hepatitis C antibody test result at screening or within 3 months before first dose of study treatment are excluded, except for the following: * Participants with positive anti-HBs antibody titer and confirmatory negative hepatitis B DNA polymerase chain reaction. * Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if they have both completed curative therapy and have a hepatitis C viral load \< quantifiable limit. 15. Any severe, acute, uncontrolled, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational or non-investigational products administration, or may interfere with the interpretation of study results, and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. Moreover, patients who, by virtue of an order issued by judicial or administrative authorities, are committed to an institution or those who cannot take part in clinical trials are excluded from this study. 16. History of significant neurological or psychiatric disorders including psychotic disorders, dementia, or seizures that would prohibit the understanding and giving of informed consent. 17. Unable or unwilling to avoid medications, supplements (e.g., St. John's wort), or foods (e.g., grapefruit, pomegranate, pomelos, star fruit, Seville oranges and their juices) that are moderate/strong inhibitors or inducers of CYP3A4 activity. Participation will be allowed if the medication, supplements, or foods are discontinued for at least 14 days prior to study entry and for the duration of the study. 18. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry. 19. Receipt of live attenuated vaccination within 30 days prior to study entry. COVID-19 vaccines that do not contain live viruses are allowed (at least one week prior to study entry).

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Conditions

The condition(s) this trial relates to.

BRCA1-related cancer predisposition BRCA2-related cancer predisposition breast cancer breast neoplasm hormone receptor-positive breast cancer Neoplasm Metastasis

As listed by the trial registrant

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

Advanced or metastatic breast cancer BRCA1 mutation BRCA2 mutation Hormone receptor positive HER-2 negative breast cancer

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

Locations

  • Agaplesion Frankfurter Diakonie Kliniken gGmbH

    RECRUITING

    Frankfurt am Main, Hesse, 60431, Germany

  • Caritas Traegergesellschaft Saarbruecken mbH (CTS)

    RECRUITING

    Saarbrücken, Saarland, 66113, Germany

  • Das Brust Zentrum - Die Frauenärzte

    RECRUITING

    Berlin, State of Berlin, 12623, Germany

  • GRN Klinik Weinheim

    RECRUITING

    Weinheim, Baden-Württembergs, 69469, Germany

  • Gemeinschaftspraxis Dr.Illmer, Dr. Wolf, Dr. Jacobasch, Dr. Freiberg-Richter

    RECRUITING

    Dresden, Saxony, Germany

  • Heinrich-Heine-Universität Düsseldorf

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Helios Universitätsklinikum Wuppertal

    RECRUITING

    Wuppertal, North Rhine-Westphalia, 42283, Germany

  • Hämatologie-Onkologie im Zentrum MVZ GmbH

    RECRUITING

    Augsburg, Bavaria, 86150, Germany

  • Institut für Versorgungsforschung Mayen

    RECRUITING

    Mayen, Rhineland-Palatinate, Germany

  • KEM Kliniken Essen-Mitte GmbH

    RECRUITING

    Essen, North Rhine-Westphalia, 45136, Germany

  • Klinikum Bayreuth

    RECRUITING

    Bayreuth, Bavaria, Germany

  • Klinikum Kassel GmbH - Frauenklinik

    RECRUITING

    Kassel, Hesse, 34125, Germany

  • Klinikum Worms

    RECRUITING

    Worms, 67550, Germany

  • Klinikum der J. W. Goethe Universität

    RECRUITING

    Frankfurt am Main, Hesse, 60590, Germany

  • MVZ Onkologische Kooperation Harz GbR

    RECRUITING

    Goslar, Lower Saxony, Germany

  • Marienhospital Bottrop gGmbH

    RECRUITING

    Bottrop, 46236, Germany

  • Marienhospital Witten

    RECRUITING

    Witten, North Rhine-Westphalia, 58452, Germany

  • MediOnko-Institut GbR

    RECRUITING

    Berlin, State of Berlin, 10367, Germany

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, Lower Saxony, Germany

  • National Center for Tumor Diseases Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

  • Rems-Murr-Klinik-Winnenden

    RECRUITING

    Winnenden, Baden-Wurttemberg, Germany

  • Robert Bosch Gesellschaft fuer medizinische Forschung mbH

    RECRUITING

    Stuttgart, Germany

  • Rotkreuzklinikum München

    RECRUITING

    München, 80634, Germany

  • Schwerpunktpraxis der Gynäkologie und Onkologie

    RECRUITING

    Fürstenwalde, Brandenburg, 15517, Germany

  • St. Josefs-Hospital, Gynäkologie und Geburtshilfe

    RECRUITING

    Wiesbaden, Hesse, 65189, Germany

  • Studien GbR Braunschweig

    RECRUITING

    Braunschweig, Lower Saxony, 38100, Germany

  • Studienzentrum Onkologie Ravensburg

    RECRUITING

    Ravensburg, 88212, Germany

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

    RECRUITING

    Mainz, Rhineland-Palatinate, 55131, Germany

  • University Hospital Carl Gustav Carus

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • University Hospital Tübingen

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universität Leipzig

    RECRUITING

    Leipzig, Saxony, Germany

  • Universitätsklinik Köln

    NOT_YET_RECRUITING

    Cologne, North Rhine-Westphalia, Germany

  • Universitätsklinikum Essen - Klinik für Frauenheilkunde und Geburtshilfe

    RECRUITING

    Essen, 45147, Germany

  • Universitätsklinikum des Saarlandes - Frauenklinik

    RECRUITING

    Homburg, 66424, Germany

  • Vinzenz Von Paul Kliniken gGmbH - Marienhospital

    RECRUITING

    Stuttgart, Baden-Wurttemberg, Germany

  • Zentrum für Gynäkologische Onkologie am MVZ Medical Center Düsseldorf GmbH

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40235, Germany

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