Breast CancerPhase 2DTPNCT03820141
Durvalumab With Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer
A Phase 2 study testing Durvalumab, Trastuzumab and Pertuzumab in people with Breast Cancer, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The purpose of this research study is to test the safety and effectiveness of using durvalumab with trastuzumab and pertuzumab in participants with human epidermal growth factor receptor 2 (HER2)-enriched breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Durvalumab, Trastuzumab and Pertuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2020to Dec 2028
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female aged >18 years at the time of study entry.
- Histologically confirmed HER2-enriched (by BluePrint) and HER2-amplified (ERBB2 mRNA >7.5-10) breast cancer.
- Estrogen receptor and progesterone receptor negative.
- Primary tumor greater than 1 cm diameter, measured by clinical examination and mammography or echography.
- Any nodal status
- Bilateral breast cancers that individually meet eligibility criteria are allowed.
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- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate organ and marrow function.
- Baseline left ventricular ejection fraction greater than or equal to 50%, as measured by multigated acquisition scan or echocardiogram.
- 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.
- Willing to provide biopsy tissues as required by the study.
- 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.
Who cannot join
- Participation in another clinical study with an investigational product within 28 days prior to the first dose of study treatment.
- 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.
- Unresolved or unstable adverse events from prior administration of another investigational drug.
- Any concurrent chemotherapy, radiation therapy, immunotherapy, or biologic therapy for cancer treatment.
- Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of study treatment.
- History of allogenic organ transplantation.
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- Active or prior documented autoimmune or inflammatory disorders.
- History of active primary immunodeficiency.
- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
- Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment.
- 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.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Patients with a mean QT interval of greater than or equal to 470ms calculated from 3 EKGs
- 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
- Patients with a LVEF less than 50%
Trial locations and contacts
1 site in 1 country.
United States1 site
Houston Methodist Cancer Center
Houston, Texas, 77030
About this study
Official title: Multicenter Phase II Trial of Durvalumab (MEDI4736) With Trastuzumab and Pertuzumab Combination in HER2-Enriched and HER2-Amplified Breast Cancer (DTP Trial)
The purpose of this research study is to test the safety and effectiveness of using durvalumab with trastuzumab and pertuzumab in participants with human epidermal growth factor receptor 2 (HER2)-enriched breast cancer.
Read the detailed description
The purpose of this research study is to test the safety and effectiveness of using durvalumab with trastuzumab and pertuzumab in participants with HER2-enriched breast cancer. The standard or usual pre-surgery treatment for this type of disease are drugs called trastuzumab and pertuzumab that target HER2. Studies have shown that trastuzumab and pertuzumab treatment can stimulate the body's own immune system to attack cancer cells. Durvalumab is a drug that also activates the immune system. The use of durvalumab together with trastuzumab and pertuzumab treatment may allow the immune system to work harder to kill cancer cells.
- Conditions
- Breast Cancer
- Being tested
- Durvalumab, Trastuzumab, Pertuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called IMFINZI, MEDI4736
programmed cell death-ligand 1 inhibitor
TrastuzumabDrug
Also called Herceptin
anti-HER2 monoclonal antibody
PertuzumabDrug
Also called Perjeta
anti-HER2 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab + Trastuzumab + Pertuzumab | Experimental | Durvalumab, trastuzumab, and pertuzumab will be administered on Day 1 every 3 weeks for 6 cycles. Trastuzumab will be administered as 8 mg/kg intravenous (IV) loading dose, followed by 6 mg/kg IV. Pertuzumab will be administered as 840 mg IV loading dose, followed by 420 mg. Durvalumab will be administered at a fixed dose of 1120 mg IV. Receives: Drug: Durvalumab; Drug: Trastuzumab; Drug: Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Response Rate (RCB-0 and RCB-1) Rate in the Breast in Patients With HER2-enriched and HER2-amplified Breast Cancer
Determination of the pathologic response rate [residual cancer burden (RCB)- 0, and RCB 1] in the breast of durvalumab with trastuzumab and pertuzumab combination in patients with HER2-enriched and HER2-amplified breast cancer.
Measured: 18 weeks
Secondary outcomes (4)
pCR Rate in the Breast in Patients Whose Tumors Have <5% and ≥5% TILs
Determine pCR rate in the breast in patients whose tumors have <5% and ≥5% tumor-infiltrating lymphocytes (TILs)
Measured: 18 weeks
pCR Rate in Patients With (PD-L1)-Positive and PD-L1-Negative Tumors
Determine pCR rate in the breast in patients with programmed cell death-ligand 1 (PD-L1)-positive and PD-L1-negative tumors
Measured: 18 weeks
Three-year Disease-free Survival (DFS) Rate in Patients Who Achieve pCR
Determination of 3-year DFS rate in patients who achieve pCR
Measured: 3 years
Number of Participants With Treatment-related Adverse Events
Number of participants with treatment-related adverse events, as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start30 Jun 2020
- Primary completion30 Oct 2024
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Polly A. Niravath, MD, The Methodist Hospital Research Institute
- Investigators
- Polly Niravath, M.D., Principal investigator, Houston Methodist Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820141
- Sponsor's protocol ID
- Pro00020917
- Acronym
- DTP
- Status last verified
- Apr 2026
- First submitted
- 25 Jan 2019
- Last updated
- 20 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Trial of Durvalumab (MEDI4736) With Trastuzumab and Pertuzumab Combination in HER2-Enriched and HER2-Amplified Breast Cancer (DTP Trial)
- ClinicalTrials.gov ID
- NCT03820141
- Acronym / sponsor ID
- DTP / Pro00020917
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Jan 2019 (actual)
- Results
- Posted 20 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test the safety and effectiveness of using durvalumab with trastuzumab and pertuzumab in participants with human epidermal growth factor receptor 2 (HER2)-enriched breast cancer.
Detailed description
The purpose of this research study is to test the safety and effectiveness of using durvalumab with trastuzumab and pertuzumab in participants with HER2-enriched breast cancer. The standard or usual pre-surgery treatment for this type of disease are drugs called trastuzumab and pertuzumab that target HER2. Studies have shown that trastuzumab and pertuzumab treatment can stimulate the body's own immune system to attack cancer cells. Durvalumab is a drug that also activates the immune system. The use of durvalumab together with trastuzumab and pertuzumab treatment may allow the immune system to work harder to kill cancer cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalumab + Trastuzumab + Pertuzumab | Experimental | Drug: Durvalumab, Drug: Trastuzumab, Drug: PertuzumabDurvalumab, trastuzumab, and pertuzumab will be administered on Day 1 every 3 weeks for 6 cycles. Trastuzumab will be administered as 8 mg/kg intravenous (IV) loading dose, followed by 6 mg/kg IV. Pertuzumab will be administered as 840 mg IV loading dose, followed by 420 mg. Durvalumab will be administered at a fixed dose of 1120 mg IV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female aged >18 years at the time of study entry.
- Histologically confirmed HER2-enriched (by BluePrint) and HER2-amplified (ERBB2 mRNA >7.5-10) breast cancer.
- Estrogen receptor and progesterone receptor negative.
- Primary tumor greater than 1 cm diameter, measured by clinical examination and mammography or echography.
- Any nodal status
Key exclusion criteria (16 listed)
- Participation in another clinical study with an investigational product within 28 days prior to the first dose of study treatment.
- 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.
- Unresolved or unstable adverse events from prior administration of another investigational drug.
- Any concurrent chemotherapy, radiation therapy, immunotherapy, or biologic therapy for cancer treatment.
- Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: IMFINZI, MEDI4736programmed cell death-ligand 1 inhibitor | Drug | Durvalumab + Trastuzumab + Pertuzumab |
| TrastuzumabAlso: Herceptinanti-HER2 monoclonal antibody | Drug | Durvalumab + Trastuzumab + Pertuzumab |
| PertuzumabAlso: Perjetaanti-HER2 monoclonal antibody | Drug | Durvalumab + Trastuzumab + Pertuzumab |
Primary outcome
Pathological Response Rate (RCB-0 and RCB-1) Rate in the Breast in Patients With HER2-enriched and HER2-amplified Breast Cancer
Time frame: 18 weeks
Determination of the pathologic response rate [residual cancer burden (RCB)- 0, and RCB 1] in the breast of durvalumab with trastuzumab and pertuzumab combination in patients with HER2-enriched and HER2-amplified breast cancer.
4 secondary outcomes
pCR Rate in the Breast in Patients Whose Tumors Have <5% and ≥5% TILs
Time frame: 18 weeks
pCR Rate in Patients With (PD-L1)-Positive and PD-L1-Negative Tumors
Time frame: 18 weeks
Three-year Disease-free Survival (DFS) Rate in Patients Who Achieve pCR
Time frame: 3 years
Number of Participants With Treatment-related Adverse Events
Time frame: 18 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Polly Niravath, M.D. principal investigator
Houston Methodist Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab, Trastuzumab and Pertuzumab in people with Breast Cancer, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Response Rate (RCB-0 and RCB-1) Rate in the Breast in Patients With HER2-enriched and HER2-amplified Breast Cancer (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.