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New treatment option for Hormone Receptor Positive HER-2 Negative Breast Cancer
Official title Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer
ClinicalTrials.gov ID: NCT06201234
What this study is testing
What is Olaparib + Elacestrant?
Olaparib + Elacestrant is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hormone receptor positive her-2 negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Trial design: Phase II, prospective, multi-center, randomized, open label, parallel group study in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutation, with 2:1 randomization into Arm A (olaparib + elacestrant) or arm B (olaparib). Treatment in either arm will be given until disease progression, unacceptable toxicity, withdrawal of patient´s consent to study participation, or end of study.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients will be eligible for study participation only if they comply with the following criteria:
- Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for scheduled visit, the...
- Female or male patients.
- Age at study entry of at least 18 years.
- 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+...
You likely can't join if
- Patients will be ineligible for study participation if they fulfill any of the following criteria:
- Known hypersensitivity reaction to one of the compounds, excipients, or substances used in this protocol.
- Active or newly diagnosed CNS metastases, including leptomeningeal carcinomatosis, carcinomatous meningitis, or radiographic signs of CNS hemorrhage...
- Presence of symptomatic metastatic visceral disease that are at risk of life-threatening complications in the short term, including but not confined...
- Inadequate organ function prior to enrolment including:
- Hemoglobin \< 9 g/dL (\< 5.6 mmol/L)
See the full eligibility criteria
Who can join
- Patients will be eligible for study participation only if they comply with the following criteria:
- 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...
- Female or male patients.
- Age at study entry of at least 18 years.
- 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).
- Patients with deleterious or suspected deleterious gBRCA1/2 mutation detected upon local testing.
- Willingness and ability to provide archived formalin fixed paraffin embedded tissue (FFPE) block or a partial block from archived tumor or metastasis.
- Indication for standard-of-care PARP inhibitor therapy and planned treatment with olaparib.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
- 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...
- Life-expectancy \> 6 months.
- 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])...
What rules you out
- Patients will be ineligible for study participation if they fulfill any of the following criteria:
- Known hypersensitivity reaction to one of the compounds, excipients, or substances used in this protocol.
- 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...
- 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)...
- 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.
- Existing contraindication against the use of the elacestrant or olaparib.
- Prior treatment with PARP inhibitors.
- 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...
- 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 hypertension at the time of screening (systolic BP \> 140 mmHg or diastolic BP \> 90 mmHg that has not been adequately treated or controlled).
- Active and current anticoagulation for treatment purposes of thrombotic events occurring \ 6 months before enrolment, or for an otherwise stable and allowed medical condition (e.g., well controlled atrial fibrillation)...
- 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...
- History of endometrial intraepithelial neoplasia in patients who have not undergone a hysterectomy.
- 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).
- 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...
- 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.
- 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...
- History of significant neurological or psychiatric disorders including psychotic disorders, dementia, or seizures that would prohibit the understanding and giving of informed consent.
- 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...
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Stuttgart, Baden-Wurttemberg, Germany
- Tübingen, Baden-Wurttemberg, Germany
- Winnenden, Baden-Wurttemberg, Germany
- Weinheim, Baden-Württembergs, Germany
- Augsburg, Bavaria, Germany
- Bayreuth, Bavaria, Germany
- Fürstenwalde, Brandenburg, Germany
- Frankfurt am Main, Hesse, Germany
- Kassel, Hesse, Germany
- Wiesbaden, Hesse, Germany
- Braunschweig, Lower Saxony, Germany
- Goslar, Lower Saxony, Germany
- Hanover, Lower Saxony, Germany
- Cologne, North Rhine-Westphalia, Germany
- Düsseldorf, North Rhine-Westphalia, Germany
- Essen, North Rhine-Westphalia, Germany
- Witten, North Rhine-Westphalia, Germany
- Wuppertal, North Rhine-Westphalia, Germany
- Mainz, Rhineland-Palatinate, Germany
- Mayen, Rhineland-Palatinate, Germany
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stuttgart, Baden-Wurttemberg, Germany; Tübingen, Baden-Wurttemberg, Germany; Winnenden, Baden-Wurttemberg, Germany; Weinheim, Baden-Württembergs, Germany; Augsburg, Bavaria, Germany; Bayreuth, Bavaria, Germany and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.