Boston, MANCT05950945Now EnrollingIRB Ready

Breast Cancer Clinical Trial in Boston, MA

Access cutting-edge breast cancer treatment through this phase 3 clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Daiichi Sankyo

Quick Self-Assessment

See if you qualify for this Boston location

Preparing your pre-screening questions…

Expert Care in Boston

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

Apply for This Boston Location

Check if you qualify for this breast cancer clinical trial in Boston, MA

Secure & Confidential

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

Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA 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 Boston site if eligible
  4. 4Begin participation

About This Breast Cancer Study in Boston

This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor \[HR\]-negative and HR-positive) unresectable and/or metastatic breast cancer.

Sponsor: Daiichi Sankyo

Who Can Participate

Inclusion Criteria

Sign and date the main informed consent form
Must agree to provide a newly obtained or archival baseline biopsy from primary and/or metastatic lesion.
Pathologically documented Breast Cancer (BC) tumor
Is unresectable and/or metastatic.
Is hormone receptor-negative or hormone receptor-positive.
Must include percentage of positively stained cells to characterize if hormone receptor-positive or -negative.
Has confirmed HER2 IHC 1+ or IHC 2+/ISH- (HER2-low) status or HER2 IHC 0 status as determined according to ASCO CAP 2018 guidelines1 based on sample collected during Tissue Screening as described above.
Was never previously HER2-positive (IHC 3+ or IHC 2+/ISH+) on prior pathology testing (per ASCO CAP guidelines).
Was never previously treated with anti-HER2 therapy in the metastatic setting.
Has had at least one and up to two prior lines of therapy in the metastatic setting.
In participants with hormone receptor-positive HER2-low metastatic BC (Cohort 3):
Has recurrent disease \<2 years from the initiation of adjuvant ET OR
Has disease progression on CDK4/6 inhibitor-based regimen within 12 months of completion of adjuvant therapy with a CDK4/6 inhibitor OR
Has disease progression within the first 12 months of CDK4/6 in the first line metastatic setting
Presence of at least one measurable lesion based on computed tomography or magnetic resonance imaging.
Participants with brain metastases are allowed in the study. The brain lesion(s) should be small (\<2 cm), untreated, asymptomatic, not requiring urgent medical intervention, and are asymptomatic and clinically stable.
Has an Eastern Cooperative Oncology Group performance status of 0 or 1.
Has a minimum life expectancy of 12 weeks at Screening.
Has a left ventricular ejection fraction ≥50% within 28 days before enrollment.
Has adequate organ and bone marrow function within 28 days before enrollment.
Has adequate treatment washout period before enrollment.
Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception.

Exclusion Criteria

Prior treatment with an antibody drug conjugate (ADC).
Uncontrolled or significant cardiovascular disease.
Has a corrected QT interval prolongation.
Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
Has spinal cord compression or clinically active central nervous system metastases.
Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, other solid tumors curatively treated, or contralateral BC.
Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.
Has a history of severe hypersensitivity reactions to other monoclonal antibodies.
Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
Active primary immunodeficiency, known uncontrolled active human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
Has history of receiving a live, attenuated vaccine (messenger RNA and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study drug.
Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline.
Is pregnant or breastfeeding or planning to become pregnant.
Lung-specific intercurrent clinically significant illnesses.
Any autoimmune, connective tissue, or inflammatory disorders.
Prior complete pneumonectomy.

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 Boston?

Yes, this clinical trial (NCT05950945) has an active research site in Boston, MA 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 Boston, MA

If you're searching for breast cancer treatment options in Boston, MA, this clinical trial (NCT05950945) 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 Boston research site is actively enrolling participants for this phase 3 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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