New Haven, CTNCT05989347Now EnrollingIRB Ready

Breast Cancer Clinical Trial in New Haven, CT

Access cutting-edge breast cancer treatment through this phase 1 clinical trial at a research site in New Haven. Study-provided care at no cost to qualified participants.

Sponsored by Yale University

Quick Self-Assessment

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Expert Care in New Haven

Access breast cancer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related breast cancer treatment provided free

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Check if you qualify for this breast cancer clinical trial in New Haven, CT

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to New Haven

    Convenient for CT 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 Haven site if eligible
  4. 4Begin participation

About This Breast Cancer Study in New Haven

The primary objective of the study is to assess metabolic plasma markers of insulin resistance in patients with early-stage HER2-negative breast cancers receiving dapagliflozin concomitant with neoadjuvant therapy.

Sponsor: Yale University

Who Can Participate

Inclusion Criteria

Women \> 18 years of age with newly diagnosed, histologically confirmed, clinical stage I-III, HER2-negative - either ER+ or triple negative - invasive breast cancer as defined by ASCO CAP guidelines for whom neoadjuvant chemotherapy would be indicated. The following chemotherapy regimens are acceptable:
Weekly or dose dense paclitaxel, followed by dose dense doxorubicin plus cyclophosphamide
Docetaxel plus cyclophosphamide
Docetaxel plus carboplatin plus or minus pembrolizumab
Paclitaxel plus carboplatin concurrent with every 3 week pembrolizumab followed by dose dense doxorubicin plus cyclophosphamide concurrent with every 3 week pembrolizumab (KEYNOTE-522 regimen; only for participants with triple negative breast cancer)
BMI ≥ 25 kg/m2
Hyperinsulinemia defined as HOMA-IR ≥ 2.5.
Willing and able to provide written informed consent for the trial.
Has at least one (1) physical 4-5-micron single H\&E slide from diagnostic biopsy available
Female participants of childbearing potential should have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female participants must be 1 year post-menopausal orsurgically sterile, Women of childbearing potential who are sexually active with a non-sterilized male partner must agree to follow their chemotherapy provider's instructions for birth control.
Participants should have adequate organ function to tolerate chemotherapy, as defined by:
peripheral granulocyte count of \> 1,500/mm3
platelet count \> 100,000/mm3
hemoglobin \>9 g/dL
total bilirubin \< 1.5 x upper limit of normal (ULN)
aspartate aminotransferase (AST) and alanine aminotransferase (ALT) each \< 1.5 x ULN
serum creatinine \< 1.5 x ULN
INR/PT/PTT each \< 1.5 x ULN
Able to swallow oral formulation of the study agent
Subjects should not donate blood while participating in this study, or for at least 90 days following the last dose of chemotherapy

Exclusion Criteria

Participants who underwent partial excisional biopsy or lumpectomy, segmental mastectomy or modified radical mastectomy or sentinel node biopsy and therefore cannot be assessed accurately for pathologic response, are not eligible.
Participants currently pregnant or breastfeeding.
Participants for whom any of the planned chemotherapies are contraindicated.
Participants with currently diagnosed type I or II diabetes mellitus.
Participants taking any antidiabetic medication that would affect insulin resistance or hyperinsulinemia (i.e. TZD, GLP-1RA, DPP-4i, SGLT2i, metformin) in the past one month.
Participants with history of hypersensitivity reaction to dapagliflozin.
Participants with eGFR \< 25.
History of recurrent (three or more occurrences within 12 months, or two or more occurrences within 6 months) urinary tract infections.
Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight) or have a history of gastrointestinal surgery.
Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, intranasal influenza, rabies, BCG, and typhoid vaccine.
Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.

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 Haven?

Yes, this clinical trial (NCT05989347) has an active research site in New Haven, CT 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.

Breast Cancer Treatment Options in New Haven, CT

If you're searching for breast cancer treatment options in New Haven, CT, this clinical trial (NCT05989347) 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 Haven research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced 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 breast cancer clinical trials near you to find additional studies recruiting in your area.

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Secure · Expert Care · New Haven, CT