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New treatment option for ER Positive, HER2 Positive Breast Cancer
Official title Elacestrant in Advanced Triple Positive Breast Cancer
ClinicalTrials.gov ID: NCT07612215
What this study is testing
What is Elacestrant?
Elacestrant is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for er positive, her2 positive 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
- The purpose of this study to assess the safety and efficacy of elacestrant, a selective estrogen receptor degrader (SERD) and dual biologic therapy, trastuzumab and pertuzumab, in patients with triple-positive breast cancer with and without an ESR1 mutation.
- Phase 2: a mid-size study of how well it works
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, women only
You may be able to join if
- Female patients aged 18 years or older.
- Should be able to provide the informed consent.
- Histologically confirmed diagnosis of triple-positive breast cancer (ER+, PR+, HER2+). In the study, ER status will be considered positive if ≥10% of...
- Disease progression on or after at least one line of NCCN recommended prior therapy
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
You likely can't join if
- Prior treatment with a SERD.
- Prior treatment with more than two lines of chemotherapy for metastatic disease, including antibody drug conjugates.
- Untreated and/or active CNS metastases.
- History of other malignancies within the past 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix).
- Inability to take oral medications, refractory or chronic nausea, gastrointestinal conditions (including significant gastric or bowel resection)...
- Known intolerance to elacestrant or any of its excipients
See the full eligibility criteria
- Female patients aged 18 years or older.
- Should be able to provide the informed consent.
- Histologically confirmed diagnosis of triple-positive breast cancer (ER+, PR+, HER2+). In the study, ER status will be considered positive if ≥10% of tumor cells demonstrate positive nuclear staining by...
- Disease progression on or after at least one line of NCCN recommended prior therapy
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Patient has adequate organ function, as defined by the following laboratory values:
- Hematologic Value:
- Hemoglobin ≥9.0 g/dL, without transfusion or growth factors within 1 week
- Neutrophils ≥1.5×103/μL or ≥1.0×103/μL for participants with benign ethnic neutropenia
- Platelets ≥100×103/μL
- Patient must have a baseline LVEF ≥50 % or ≥ institutional LLN within 28 days prior to the study treatment.
- Sex and Contraceptive/Barrier Requirements
- While on study treatment a participant must not breastfeed or be pregnant
- Have a negative highly sensitive (eg, beta-human chorionic gonadotropin [β-hCG]) pregnancy test at screening and agree to further pregnancy tests per the protocol.
- Practice at least 1 highly effective method of contraception; if oral contraceptives are used, a barrier method of contraception must also be used.
- Female participants (pre- or perimenopausal) must use the appropriate highly effective, non-hormonal contraception method within 28 days of the first dose of study treatment, until 7 months after the last dose of study...
- Prior treatment with a SERD.
- Prior treatment with more than two lines of chemotherapy for metastatic disease, including antibody drug conjugates.
- Untreated and/or active CNS metastases.
- History of other malignancies within the past 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix).
- Inability to take oral medications, refractory or chronic nausea, gastrointestinal conditions (including significant gastric or bowel resection), history of malabsorption syndrome, or any other uncontrolled...
- Known intolerance to elacestrant or any of its excipients
- Uncontrolled active infection or intercurrent illness.
- Patients with known HBV and/or HCV infection must have undetectable viral load during screening (See Appendix B).
- Patients known to be HIV+ are allowed if they have undetectable viral load at baseline.
- Patients who are on any of the prohibited medications listed in sections 7.6 and 7.4.
- Male participants will not be included because Male breast cancer is rare and may differ biologically and hormonally, which would introduce heterogeneity difficult to address in a small, single arm phase II trial.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
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 female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. 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.