New combo therapy targets hard-to-treat breast tumors
NCT ID NCT06827613
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug combination (invikafusp alfa plus sacituzumab govitecan) in people with advanced breast cancers that cannot be removed by surgery or have spread. The goal is to see if the combination is safe and can shrink or control tumors. About 50 adults with triple-negative or hormone-receptor-positive/HER2-negative breast cancer will take part.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Have measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI. Cutaneous or subcutaneous lesions must be measurable by calipers. 2. Tumor Type: * mTNBC (Safety Run-in and Cohort A): Progression or recurrence of locally advanced or metastatic TNBC * HR+/HER2- mBC (Safety Run-in and Cohort B): Progression or recurrence of locally advanced or metastatic HR+/HER2- breast cancer 3. Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment: No concurrent treatment for CNS disease (eg, surgery, radiation, corticosteroids \> 10 mg prednisone/day or equivalent); No concurrent leptomeningeal disease or cord compression. Exclusion Criteria: 1. History of known autoimmune disease with exceptions of: * Vitiligo * Psoriasis * Atopic dermatitis or other autoimmune skin condition not requiring systemic treatment * History of Graves' disease, now euthyroid for \> 4 weeks * Hypothyroidism managed by thyroid replacement * Alopecia * Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs * Adrenal insufficiency well-controlled on replacement therapy 2. Major surgery or traumatic injury within 8 weeks before first dose of study intervention 3. Unhealed wounds from surgery or injury 4. Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises 5. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study intervention. 6. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study intervention administration. Inactivated annual influenza vaccination is allowed. 7. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease. 8. Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas. 9. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation) 10. Treatment with \>10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study intervention. Exceptions may be made for participants who have had allergic reactions to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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BC Cancer
RECRUITINGVancouver, British Columbia, V5Z 1K1, Canada
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Massachusetts General Hospital Cancer Center
RECRUITINGBoston, Massachusetts, 02114, United States
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Ohio State University Comprehensive Cancer Center
RECRUITINGColumbus, Ohio, 43212, United States
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Princess Margaret Cancer Centre
RECRUITINGToronto, Ontario, M5G 2C4, Canada
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Sarah Cannon Research Institute
RECRUITINGNashville, Tennessee, 37203, United States
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UCLA Health
RECRUITINGLos Angeles, California, 90095, United States
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USC Norris Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90033, United States
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UT Health San Antonio MD Anderson Cancer Center
RECRUITINGSan Antonio, Texas, 78229, United States
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- Real-world data on palbociclib combo for breast cancer in japan