Phase
Condition
Breast Cancer
Cancer
Treatment
BB-1701
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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.
Study Design
Connect with a study center
CHU Besançon - Hôpital Jean Minjoz
Besancon,
FranceSite Not Available
CHU Besançon - Hôpital Jean Minjoz
Besançon,
FranceSite Not Available
Institut Régional du Cancer de Montpellier
Montpellier,
FranceSite Not Available
Centre Armoricain de Radiotherapie Imagerie & Oncologie (CARIO)
Plerin,
FranceSite Not Available
Centre Armoricain de Radiotherapie Imagerie & Oncologie (CARIO)
Plérin,
FranceSite Not Available
Institut de Cancerologie de Ouest (ICO) - Saint-Herblain
Saint-Herblain,
FranceSite Not Available
Institut de Cancerologie de Ouest (ICO) - Saint-Herblain
Saint-Herblain Cedex,
FranceSite Not Available
Nagoya University Hospital
Nagoya Shi, Aichi
JapanSite Not Available
Nagoya University Hospital
Nagoya, Aichi-ken
JapanSite Not Available
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Hiroshima
JapanSite Not Available
Hiroshima City Hiroshima Citizens Hospital
Hiroshima-shi, Hiroshima-ken
JapanSite Not Available
Hokkaido University Hospital
Sapporo, Hokkaido
JapanSite Not Available
Hyogo Medical University Hospital
Nishinomiya-shi, Hyōgo
JapanSite Not Available
Sagara Hospital, Social Medical Corporation Hakuaikai
Kagoshima Shi, Kagoshima
JapanSite Not Available
Sagara Hospital, Social Medical Corporation Hakuaikai
Kagoshima, Kagoshima-ken
JapanSite Not Available
Kanagawa Cancer Center
Yokohama, Kanagawa
JapanSite Not Available
Kanagawa Cancer Center
Yokohama Shi, Kanagawa
JapanSite Not Available
Kyoto University Hospital
Sakyo-ku, Kyoto
JapanSite Not Available
Tohoku University Hospital
Sendai, Miyagi
JapanSite Not Available
Tohoku University Hospital
Sendai Shi, Miyagi
JapanSite Not Available
Okayama University Hospital
Okayama Shi, Okayama
JapanSite Not Available
Okayama University Hospital
Okayama, Okayama-ken
JapanSite Not Available
Saitama Medical University International Medical Center
Hidaka-shi, Saitama
JapanSite Not Available
Saitama Cancer Center
Kitaadachi-gun, Saitama
JapanSite Not Available
National Cancer Center Hospital (NCCH)
Chuo-Ku, Tokyo
JapanSite Not Available
St. Luke's International Hospital
Chuou-ku, Tokyo
JapanSite Not Available
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto Ku, Tokyo
JapanSite Not Available
Showa Medical University
Shinagawa Ku, Tokyo
JapanSite Not Available
Showa University
Shinagawa Ku, Tokyo
JapanSite Not Available
Hospital Universitario Vall d'Hebron
Barcelona,
SpainSite Not Available
HM Universitario Sanchinarro
Madrid,
SpainSite Not Available
Hospital Beata María Ana
Madrid,
SpainSite Not Available
Cancer and Blood Specialty Clinic
Los Alamitos, California 90720
United StatesSite Not Available
UCLA Center for East-West Medicine
Los Angeles, California 90095
United StatesSite Not Available
UCSF
San Francisco, California 94143-2208
United StatesSite Not Available
Yale New Haven Hospital
New Haven, Connecticut 06510
United StatesSite Not Available
AdventHealth Cancer Institute - Orlando
Orlando, Florida 32804
United StatesSite Not Available
Moffitt Cancer Center
Tampa, Florida 33612-9416
United StatesSite Not Available
Fort Wayne Medical Oncology & Hematology
Fort Wayne, Indiana 48604
United StatesSite Not Available
Community Cancer Center South
Indianapolis, Indiana 46227
United StatesSite Not Available
Mission Blood and Cancer
Des Moines, Iowa 50309
United StatesSite Not Available
Mission Cancer and Blood
Des Moines, Iowa 50309
United StatesActive - Recruiting
University of Michigan Hospital
Ann Arbor, Michigan 48109-5000
United StatesSite Not Available
Washington University in St. Louis School of Medicine
Saint Louis, Missouri 63110-1032
United StatesSite Not Available
Washington University in St. Louis School of Medicine
St Louis, Missouri 63110-1032
United StatesSite Not Available
NHO Revive Research Institute LLC
Lincoln, Nebraska 68506
United StatesSite Not Available
Nebraska Cancer Specialist
Omaha, Nebraska 68130-2042
United StatesSite Not Available
Astera Cancer Care
East Brunswick, New Jersey 08816
United StatesSite Not Available
Summit Medical Group
Florham Park, New Jersey 07932-1049
United StatesSite Not Available
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United StatesSite Not Available
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico 87109
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195-0001
United StatesSite Not Available
Cleveland Clinic - Fairview Hospital - Cancer Center (Moll Cancer Center)
Cleveland, Ohio 44111
United StatesSite Not Available
Cleveland Clinic - Hillcrest Hospital - Hillcrest Cancer Center
Cleveland, Ohio 44124
United StatesSite Not Available
Oregon Oncology Specialists
Salem, Oregon 97301
United StatesSite Not Available
UPMC CancerCenter at Magee - Womens Hospital
Pittsburgh, Pennsylvania 15213-3108
United StatesSite Not Available
St. Francis Cancer Center
Greenville, South Carolina 29607-5253
United StatesSite Not Available
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United StatesSite Not Available
The West Clinic, PLLC dba West Cancer Cente
Germantown, Tennessee 38138-1762
United StatesSite Not Available
Northwest Medical Specialties
Puyallup, Washington 98373-1428
United StatesSite Not Available

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