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New drug targets Hard-to-Treat breast cancers

NCT ID NCT06188559

Disease control Sponsor: Eisai Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests BB-1701, a drug that targets HER2 on breast cancer cells, in 56 people with advanced breast cancer that is HER2-positive or HER2-low. The study has two parts: first to find the best dose, then to see how well it shrinks tumors. Participants receive the drug by IV every three weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BB-1701 (an antibody-drug conjugate targeting HER2)
What this could lead to
If successful, this could provide a new treatment option for people with HER2-positive or HER2-low breast cancer that has spread or cannot be removed.
What could go wrong
This is an early-phase trial with only 56 participants, so results may not apply to everyone. Side effects are possible, and the drug may not shrink tumors as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

56 people

The number who actually took part.

Started

Apr 2024

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Male or female, aged \>=18 years at the time of informed consent. * Metastatic or unresectable BC that is histologically confirmed to be either HER2-positive (defined as an immunohistochemistry \[IHC\] status of 3+, or a positive in situ hybridization \[ISH\] test \[fluorescence, chromogenic, or silver-enhanced ISH\] if IHC status is 2+) or HER2-low (defined as an IHC status of 1+, or 2+ and negative ISH) per the American Society of Clinical Oncology/College of American Pathology guidelines as documented prior to trastuzumab deruxtecan (T-DXd) treatment. * Must have previously received T-DXd. * Sufficient tumor tissue is required for HER2 status testing at a central laboratory. * Measurable disease per RECIST 1.1 as assessed by the investigator. Participants with bone only disease may be eligible if there is a measurable soft tissue component associated with the bone lesion. * Must have previously received at least 1 but no more than 3 prior chemotherapy-based regimes in the unresectable or metastatic setting. If recurrence occurred during or within 6 months of (neo) adjuvant chemotherapy, this would count as 1 line of chemotherapy. * If HR-positive HER2-low BC, must have previously received endocrine therapy and is not expected to further benefit from it. * ECOG PS 0 or 1. * Life expectancy of at least 3 months. * Adequate organ function and laboratory parameters. Exclusion Criteria * Presence of brain or subdural metastases, unless participant has completed local therapy and has discontinued the use of corticosteroids for this indication for at least 2 weeks prior to starting treatment in this study. * Diagnosed with meningeal carcinomatosis. * Received anticancer therapy (chemotherapy or other systemic anticancer therapies, immunotherapy, radiation therapy, etc) or an investigational drug or device within the past 28 days or 5 half-lives, whichever is shorter. * Prior treatment with eribulin. * Any prior allergic reactions of Grade \>=3 to monoclonal antibodies or contraindication to the receipt of corticosteroids or any of the excipients (investigators should refer to the prescribing information for the selected corticosteroid). * Residual toxic effects of prior therapies or surgical procedures that is Grade \>=2 (except alopecia or anemia). * Grade \>=2 peripheral neuropathy or history of Grade \>=3 peripheral neuropathy or discontinued any prior treatment due to peripheral neuropathy. * Active pneumonitis/interstitial lung disease (ILD) or any clinically significant lung disease (example, chronic obstructive pulmonary disease), history of Grade \>=2 pneumonitis/ILD, or received radiotherapy to lung fields within 12 months of Cycle 1 Day 1 of study treatment. * Congestive heart failure greater than (\>) New York Heart Association Class II or left ventricular ejection fraction (LVEF) less than (\<) 50 percent (%) measured by multigated acquisition scan (MUGA) or echocardiogram. * Has a corrected QT interval prolongation per Fridericia formula (QTcF) \>470 millisecond (ms) (for both males and females) based on screening triplicate 12-lead ECG. * Concomitant active infection requiring systemic treatment, except: * If known to be human immunodeficiency virus (HIV)-positive, must be on anti-HIV therapy for at least 4 weeks and have a clusters of differentiation 4+ T-cell (CD4+) count \>=350 cells per microliter (cells/mcL) and an HIV viral load \<400 copies per milliliter (copies/mL). * If meets the criteria for anti-hepatitis B virus (HBV) therapy, must agree to take anti-HBV therapy, if known to be HBV-positive as defined by positive hepatitis B surface antigen or hepatitis B core antibody. HBV viral load must be undetectable. * If known to be hepatitis C virus (HCV)-positive must have completed curative therapy for HCV. HCV viral load must be undetectable. * Known history of active bacillus tuberculosis (TB). * Any medical or other condition which, in the opinion of the investigator would preclude the participant's participation in the clinical study.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • AdventHealth Cancer Institute - Orlando

    Orlando, Florida, 32804, United States

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816, United States

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105, United States

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, France

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720, United States

  • Centre Armoricain de Radiotherapie Imagerie & Oncologie (CARIO)

    Plérin, France

  • Cleveland Clinic

    Cleveland, Ohio, 44195-0001, United States

  • Cleveland Clinic - Fairview Hospital - Cancer Center (Moll Cancer Center)

    Cleveland, Ohio, 44111, United States

  • Cleveland Clinic - Hillcrest Hospital - Hillcrest Cancer Center

    Cleveland, Ohio, 44124, United States

  • Community Cancer Center South

    Indianapolis, Indiana, 46227, United States

  • Fort Wayne Medical Oncology & Hematology

    Fort Wayne, Indiana, 48604, United States

  • HM Universitario Sanchinarro

    Madrid, Spain

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, Hiroshima, Japan

  • Hokkaido University Hospital

    Sapporo, Hokkaido, Japan

  • Hospital Beata María Ana

    Madrid, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, Spain

  • Hyogo Medical University Hospital

    Nishinomiya-shi, Hyōgo, Japan

  • Institut Régional du Cancer de Montpellier

    Montpellier, France

  • Institut de Cancerologie de Ouest (ICO) - Saint-Herblain

    Saint-Herblain, France

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, Japan

  • Kyoto University Hospital

    Sakyo-ku, Kyoto, Japan

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • Mission Blood and Cancer

    Des Moines, Iowa, 50309, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612-9416, United States

  • NHO Revive Research Institute LLC

    Lincoln, Nebraska, 68506, United States

  • Nagoya University Hospital

    Nagoya, Aichi-ken, Japan

  • National Cancer Center Hospital (NCCH)

    Chuo-Ku, Tokyo, Japan

  • Nebraska Cancer Specialist

    Omaha, Nebraska, 68130-2042, United States

  • New Mexico Oncology Hematology Consultants

    Albuquerque, New Mexico, 87109, United States

  • Northwest Medical Specialties

    Puyallup, Washington, 98373-1428, United States

  • Okayama University Hospital

    Okayama, Okayama-ken, Japan

  • Oregon Oncology Specialists

    Salem, Oregon, 97301, United States

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903, United States

  • Sagara Hospital, Social Medical Corporation Hakuaikai

    Kagoshima, Kagoshima-ken, Japan

  • Saitama Cancer Center

    Kitaadachi-gun, Saitama, Japan

  • Saitama Medical University International Medical Center

    Hidaka-shi, Saitama, Japan

  • Showa Medical University

    Shinagawa Ku, Tokyo, Japan

  • St. Francis Cancer Center

    Greenville, South Carolina, 29607-5253, United States

  • St. Luke's International Hospital

    Chuou-ku, Tokyo, Japan

  • Summit Medical Group

    Florham Park, New Jersey, 07932-1049, United States

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto Ku, Tokyo, Japan

  • The West Clinic, PLLC dba West Cancer Cente

    Germantown, Tennessee, 38138-1762, United States

  • Tohoku University Hospital

    Sendai, Miyagi, Japan

  • UCLA Center for East-West Medicine

    Los Angeles, California, 90095, United States

  • UCSF

    San Francisco, California, 94143-2208, United States

  • UPMC CancerCenter at Magee - Womens Hospital

    Pittsburgh, Pennsylvania, 15213-3108, United States

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109-5000, United States

  • Washington University in St. Louis School of Medicine

    St Louis, Missouri, 63110-1032, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510, United States

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Other studies related to the condition(s) this trial covers.