New drug cocktail targets Hard-to-Treat breast cancer
NCT ID NCT03820141
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding the immunotherapy drug durvalumab to two standard targeted drugs (trastuzumab and pertuzumab) can shrink tumors more effectively in people with HER2-enriched breast cancer. The study involves 51 participants and measures how many have no or minimal cancer remaining after treatment. The goal is to find a better pre-surgery option for this aggressive cancer type.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- durvalumab (an immunotherapy drug) combined with trastuzumab and pertuzumab (targeted antibody drugs)
- What this could lead to
- If successful, this combination could offer a more effective treatment option for HER2-enriched breast cancer, potentially increasing the chance of eliminating the tumor before surgery.
- What could go wrong
- This is a small, early-phase trial (51 people) without a comparison group, so results may not apply broadly. Adding immunotherapy can cause immune-related side effects.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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51 people
The number who actually took part.
- Started
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Jun 2020
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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Female participants only
- 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. Female aged \>18 years at the time of study entry. 2. Histologically confirmed HER2-enriched (by BluePrint) and HER2-amplified (ERBB2 mRNA \>7.5-10) breast cancer. 3. Estrogen receptor and progesterone receptor negative. 4. Primary tumor greater than 1 cm diameter, measured by clinical examination and mammography or echography. 5. Any nodal status 6. Bilateral breast cancers that individually meet eligibility criteria are allowed. 7. Eastern Cooperative Oncology Group performance status of 0 or 1. 8. Adequate organ and marrow function. 9. Baseline left ventricular ejection fraction greater than or equal to 50%, as measured by multigated acquisition scan or echocardiogram. 10. Evidence of postmenopausal status or negative serum pregnancy test for premenopausal patients. Negative serum beta-human chorionic gonadotropin pregnancy test within 7 days prior to the first dose of study treatment for premenopausal patients. 11. Willing to provide biopsy tissues as required by the study. 12. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up. Exclusion Criteria: 1. Participation in another clinical study with an investigational product within 28 days prior to the first dose of study treatment. 2. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study. 3. Unresolved or unstable adverse events from prior administration of another investigational drug. 4. Any concurrent chemotherapy, radiation therapy, immunotherapy, or biologic therapy for cancer treatment. 5. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of study treatment. 6. History of allogenic organ transplantation. 7. Active or prior documented autoimmune or inflammatory disorders. 8. History of active primary immunodeficiency. 9. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus. 10. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment. 11. Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment. 12. Patients who are pregnant or breastfeeding or patients of reproductive potential who are not willing to employ effective birth control from screening to 7 months after the last dose of study treatment. 13. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. 14. Patients with a mean QT interval of greater than or equal to 470ms calculated from 3 EKGs 15. Patients with underlying cardiovascular conditions that have recently undergone interventions including: cardiac ventricular arrhythmia requiring medication, history of second or third degree AV blocks, myocardial infarction with the previous year, congestive heart failure, and unstable angina 16. Patients with a LVEF less than 50%
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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.
Contacts and locations
Locations
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Houston Methodist Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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