Elacestrant in Advanced Triple Positive Breast Cancer
Elacestrant in Advanced Triple Positive Breast Cancer, a Phase II Evaluation (ELATE)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe elacestrant is and how well it works with trastuzumab and pertuzumab. It is for women with advanced triple-positive breast cancer, which has three markers called ER, PR, and HER2. Women with or without a change in the ESR1 gene may join.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women age 18 or older who can give informed consent to join.
- Breast cancer confirmed by a tissue test that meets the study’s ER, PR, and HER2 rules. Some women without the PR marker may join with the study leader’s approval.
- Cancer has gotten worse during or after at least one recommended treatment.
- Able to care for yourself and be out of bed for at least half the day.
- Blood tests show enough red blood cells, infection-fighting white blood cells, and platelets, which help blood clot.
- A heart test within 28 days before treatment shows the heart pumps well enough.
- Not pregnant or breastfeeding, with a negative pregnancy test at screening and more tests during the study.
- Follow the study’s birth control rules. Women before or near menopause must use highly effective, non-hormonal birth control through at least 7 months after the last dose.
Who can't join
- Past treatment with a SERD, a drug that breaks down estrogen receptors.
- More than two past rounds of different chemotherapy treatments for cancer that has spread, including antibody-drug treatments.
- Untreated or active cancer that has spread to the brain or spinal cord.
- Another cancer within the past 5 years, except certain treated skin cancers or early cancer limited to the cervix’s surface.
- Unable to take pills, or ongoing nausea or stomach or bowel problems that affect how the body takes in the study drug.
- Known inability to tolerate elacestrant or any of its ingredients.
- An uncontrolled active infection or other illness. People with hepatitis B, hepatitis C, or HIV must have no virus detected by the required blood tests.
- Taking medicines that the study does not allow.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Female patients aged 18 years or older. 2. Should be able to provide the informed consent. 3. 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 immunohistochemistry, with PR\>1%. Patients may be considered to be enrolled on study with prior approval of study PI if ER \>10% and without PGR positivity HER2 status will be considered positive with the score of 3+ with immunohistochemistry staining or 2+ by immunohistochemistry and FISH -amplified as per ASCO CAP guidelines (2023)" 4. Disease progression on or after at least one line of NCCN recommended prior therapy 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 6. Patient has adequate organ function, as defined by the following laboratory values: 1. Hematologic Value: 2. Hemoglobin ≥9.0 g/dL, without transfusion or growth factors within 1 week 3. Neutrophils ≥1.5×103/μL or ≥1.0×103/μL for participants with benign ethnic neutropenia 4. Platelets ≥100×103/μL 5. Patient must have a baseline LVEF ≥50 % or ≥ institutional LLN within 28 days prior to the study treatment. 7. Sex and Contraceptive/Barrier Requirements 1. While on study treatment a participant must not breastfeed or be pregnant 2. 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. 3. Practice at least 1 highly effective method of contraception; if oral contraceptives are used, a barrier method of contraception must also be used. 4. 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 treatment (or longer based on companion drug). Highly effective methods of contraception are those methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include: i. intrauterine device (IUD) ii. bilateral tubal occlusion iii. vasectomized partner iv. sexual abstinence (i.e., refraining from heterosexual intercourse during the study treatment and 120 days after the last dose of study treatment). e. Unacceptable contraception methods: Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea methods are not acceptable methods of contraception. Female condom and male condom should not be used together. Exclusion Criteria: 1. Prior treatment with a SERD. 2. Prior treatment with more than two lines of chemotherapy for metastatic disease, including antibody drug conjugates. 3. Untreated and/or active CNS metastases. 4. History of other malignancies within the past 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix). 5. 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 gastrointestinal condition that impact the absorption of the study drug 6. Known intolerance to elacestrant or any of its excipients 7. Uncontrolled active infection or intercurrent illness. 1. Patients with known HBV and/or HCV infection must have undetectable viral load during screening (See Appendix B). 2. Patients known to be HIV+ are allowed if they have undetectable viral load at baseline. 8. Patients who are on any of the prohibited medications listed in sections 7.6 and 7.4. 9. 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.
Study sites (1)
NY
- NYU Langone Health · New York, NY 10016More trials in New York