New York, NYNCT07612215Now EnrollingIRB Ready

ER Positive, HER2 Positive Breast Cancer Clinical Trial in New York, NY

Access cutting-edge er positive, her2 positive breast cancer treatment through this phase 1/2 clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by NYU Langone Health

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Expert Care in New York

Access er positive, her2 positive breast cancer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related er positive, her2 positive breast cancer treatment provided free

Apply for This New York Location

Check if you qualify for this er positive, her2 positive breast cancer clinical trial in New York, NY

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Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This ER Positive, HER2 Positive Breast Cancer Study in New York

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.

Sponsor: NYU Langone Health

Who Can Participate

Inclusion 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 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)"
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 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

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 gastrointestinal condition that impact the absorption of the study drug
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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT07612215) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

ER Positive, HER2 Positive Breast Cancer Treatment Options in New York, NY

If you're searching for er positive, her2 positive breast cancer treatment options in New York, NY, this clinical trial (NCT07612215) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced er positive, her2 positive breast cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all er positive, her2 positive breast cancer clinical trials near you to find additional studies recruiting in your area.

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