HER2-positive Breast CancerPhase 2NCT03747120
Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]
A Phase 2 study testing Paclitaxel, Trastuzumab and Pertuzumab in people with HER2-positive Breast Cancer and Breast Cancer, run by University of Texas Southwestern Medical Center at 5 sites in United States.
Trial summary
A phase 2 open-label, randomized, multi-center trial to evaluate the efficacy and safety of neoadjuvant trastuzumab, pertuzumab and weekly paclitaxel (THP) as compared to neoadjuvant trastuzumab, pertuzumab, pembrolizumab and weekly paclitaxel (THP-pembrolizumab), or neoadjuvant trastuzumab, pembrolizumab and weekly… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer, Breast Cancer
- What is being tested?
- Paclitaxel, Trastuzumab and Pertuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Jan 2019to Dec 2029
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/female patients with histologically confirmed invasive HER2-positive (by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines) unilateral breast cancer
- Have previously untreated non-metastaic (M0), cT2-4N0 or cT1-4N1-3 (biopsies of clinically suspicious lymph nodes to confirm nodal status is encouraged).
- Multifocal/centric disease is permitted if all suspicious foci have been biopsied and are consistent with HER2-positive (by ASCO/CAP guidelines) invasive breast cancer
- Be a male or female subject 18 years of age on the day of signing informed consent
- Male Participants: A male participant must agree to use a contraception as detailed in Appendix C of this protocol during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period.
- Female Participants: A female participant is eligible to participate if she is not pregnant (see Appendix C), not breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) as defined in Appendix C OR b.) A WOCBP who agrees to follow the contraceptive guidance in Appendix C during the treatment period and for at least 6 months after the last dose of study treatment.
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- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Provides adequate archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. Note: If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Have adequate organ function as defined by the following parameters. Specimens must be collected within 7 days prior to the start of study treatment.
- Absolute neutrophil count (ANC) ≥1500/µL
- Platelets ≥100 000/µL
- Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La
- Renal Creatinine (≤1.5 × ULN OR) OR Measured or calculated(b) creatinine clearance (≥30 mL/min for participant with creatinine levels) (GFR can also be used in place of creatinine or CrCl) (>1.5 × institutional ULN)
- Hepatic Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
- Coagulation International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
- Cardiac Echocardiogram or MUGA (multigated radionuclide angiography) Baseline LVEF ≥ 55%
Who cannot join
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.
- Has received prior therapy with an anti-PD-1 (programmed death protein 1), anti-PD-L1 (Programmed death-ligand 1), or anti PD L2 (Programmed death-ligand 2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization. Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
- Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
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- Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has a known additional malignancy that is progressing or has required active systemic treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has a known active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C virus (i.d. HCV RNA [qualitative] is detected) infection.
- Has a known history of active TB (Bacillus Tuberculosis).
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
- Has significant cardiovascular disease, such as:
- History of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months
- Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA class III or IV
- Angina pectoris requiring anti-anginal medication, uncontrolled arrhythmias, or uncontrolled hypertension (systolic blood pressure > 180mmHg and/or diastolic blood pressure > 100mmHg).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
New Mexico Cancer Center
Albuquerque, New Mexico, 87109
Massachusetts General Hospital
Boston, Massachusetts, 02114
UT Southwestern Medical Center
Dallas, Texas, 75006-7541
Cedars Sinai Medical Center
Los Angeles, California, 90048
Providence Cancer Institute
Portland, Oregon, 97213
About this study
Official title: Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab (neoHIP)
A phase 2 open-label, randomized, multi-center trial to evaluate the efficacy and safety of neoadjuvant trastuzumab, pertuzumab and weekly paclitaxel (THP) as compared to neoadjuvant trastuzumab, pertuzumab, pembrolizumab and weekly paclitaxel (THP-pembrolizumab), or neoadjuvant trastuzumab, pembrolizumab and weekly paclitaxel (TH-pembrolizumab ) in chemo naive patients with invasive human epidermal growth factor receptor 2 (HER2) positive breast cancer whose primary tumors are > 2 cm and/or clinically lymph node positive. Treatment will be followed by standard of care breast surgery and physician's choice adjuvant therapy per standard of care.
Read the detailed description
A phase 2 open-label, randomized, multi-center trial to evaluate the efficacy and safety of neoadjuvant trastuzumab, pertuzumab and weekly paclitaxel (THP) as compared to neoadjuvant trastuzumab, pertuzumab, pembrolizumab and weekly paclitaxel (THP-pembrolizumab), or neoadjuvant trastuzumab, pembrolizumab and weekly paclitaxel (TH-pembrolizumab) in chemo naive patients with invasive human epidermal growth factor receptor 2 (HER2) positive breast cancer whose primary tumors are > 2 cm and/or clinically lymph node positive.
Patients will be randomized to either Arm A: THP (trastuzumab, pertuzumab and weekly paclitaxel), Arm B: THP-pembrolizumab (trastuzumab, pertuzumab, pembrolizumab) and weekly paclitaxel) or Arm C: TH-pembrolizumab (trastuzumab, pembrolizumab and weekly paclitaxel). Patients will be stratified according to hormone receptor status and lymph node status. All patients will be treated weekly every three weeks for four cycles (only paclitaxel will be administered weekly) and then undergo breast surgery. Arm A patients will be regarded as the reference group.
- Conditions
- HER2-positive Breast Cancer, Breast Cancer
- Being tested
- Paclitaxel, Trastuzumab, Pertuzumab, Pembrolizumab
- Keywords
- her2-positive breast cancer, Breast Cancer, Pembrolizumab, Immunotherapy, Neoadjuvant her2 targeted therapy, Trastuzumab, Pertuzumab, Paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol
All subjects will receive Paclitaxel weekly for 12 weeks
TrastuzumabDrug
Also called Herceptin
All subjects will receive Trastuzumab every 3 weeks
PertuzumabDrug
Also called Perjeta
Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
PembrolizumabDrug
Also called Keytruda
Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm A: THP | Active comparator | Arm A: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion. Receives: Drug: Paclitaxel; Drug: Trastuzumab; Drug: Pertuzumab |
| Arm B: THP-Pembrolizumab | Experimental | Arm B: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion. Receives: Drug: Paclitaxel; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Pembrolizumab |
| Arm C: TH-Pembrolizumab | Experimental | Arm C: Paclitaxel weekly x12 + Trastuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion. Receives: Drug: Paclitaxel; Drug: Trastuzumab; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
Proportion of subjects without residual invasive cancer in the breast and axilla from randomization to definitive surgery.
- Residual invasive cancer defined based on hematoxylin and eosin evaluation of complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by pathologist assessment.
Measured: 16 weeks from randomization
Secondary outcomes (9)
Pathological Complete Invasive and in Situ Response Rate (Breast and Axilla)
Proportion of subjects without residual invasive and in situ cancer in the breast and axilla disease from randomization to definitive surgery.
- Residual invasive cancer and in situ disease defined based on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by pathological assessment.
Measured: 16 weeks from randomization
Pathological Complete Response Rate (pCR) in Breast Only
Proportion of subjects without residual invasive cancer in the breast from randomization to definitive surgery.
- Residual invasive breast cancer defined based on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant systemic therapy by pathological assessment.
Measured: 16 weeks from randomization
Residual Cancer Burden (RCB)
Proportion of subjects with RCB 0-I, II or III from randomization to definitive surgery.
-Residual Cancer Burden defined based on the RCB index, a component of four pathological parameters: bi-dimensional diameter of primary tumor bed, percent of cellularity in the tumor bed, number of involved lymph nodes and size of the largest nodal metastasis.
The RCB possible scores are:
- RCB-0: Represents a pathologic complete response (pCR), meaning no residual invasive breast cancer was found after neoadjuvant therapy.
- RCB-I: Indicates a minimal residual disease burden.
- RCB-II: Represents a moderate residual disease burden.
- RCB-III: Indicates an extensive residual disease burden. Therefore, higher score indicates worse outcome.
Measured: 16 weeks from randomization
Breast Conserving Surgery Rate
Proportion of subjects who achieved breast conserving surgery out of the intent-to-treat population without inflammatory breast cancer from randomization to definitive surgery (breast conserving surgery).
Measured: 16 weeks from randomization
Event Free Survival
Mean difference in time (in months) from randomization to any of the following events progression of disease that precludes surgery, local or distant recurrence, or death due to any cause.
Measured: 36 months from randomization
Invasive Disease-free Survival (IDFS)
Mean difference in time (in months) from date of surgery (date of no disease) to the first documentation of invasive progressive disease or death.
Measured: 33 months from surgery
Overall Survival
Mean difference in time (in months) from randomization to death.
Measured: 36 months from randomization
Symptomatic Cardiac Events and Asymptomatic LVEF Events
This outcome measure was inadvertently included in the original registration of the record (by a different organization- this is a transfer record). This specific outcome was never a pre-specified outcome within any version of the protocol. The error was not caught until we began to enter and report results. No data was ever collected for this outcome and hence no data can be reported. There is no plan to collect or analyze data in the future as the outcome was added in error and should have been removed prior to reporting results.
Measured: 36 months from randomization
AEs and SAEs
Incidence and severity of adverse events (AE) and serious adverse events (SAE) from cycle 1 day 1 until 30 days post-surgery.
-AEs and SAEs based on CTCAE 5.0
Measured: 20 weeks from treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start25 Jan 2019
- Primary completion8 Nov 2024
- Study completionDec 2029 (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 HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1:1 randomization
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Breast Cancer Research Foundation
- Responsible party
- Principal investigator, Heather McArthur, University of Texas Southwestern Medical Center
- Investigators
- Heather McArthur, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747120
- Sponsor's protocol ID
- STU-2021-0558
- Status last verified
- Jun 2026
- First submitted
- 16 Nov 2018
- Last updated
- 8 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab (neoHIP)
- ClinicalTrials.gov ID
- NCT03747120
- Acronym / sponsor ID
- STU-2021-0558
- Conditions
- HER2-positive Breast Cancer, Breast Cancer
- Keywords
- her2-positive breast cancer, Breast Cancer, Pembrolizumab, Immunotherapy, Neoadjuvant her2 targeted therapy, Trastuzumab, Pertuzumab, Paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Breast Cancer Research Foundation
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- Dec 2029 (estimated)
- First posted
- 20 Nov 2018 (actual)
- Results
- Posted 8 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 2 open-label, randomized, multi-center trial to evaluate the efficacy and safety of neoadjuvant trastuzumab, pertuzumab and weekly paclitaxel (THP) as compared to neoadjuvant trastuzumab, pertuzumab, pembrolizumab and weekly paclitaxel (THP-pembrolizumab), or neoadjuvant trastuzumab, pembrolizumab and weekly paclitaxel (TH-pembrolizumab ) in chemo naive patients with invasive human epidermal growth factor receptor 2 (HER2) positive breast cancer whose primary tumors are > 2 cm and/or clinically lymph node positive. Treatment will be followed by standard of care breast surgery and physician's choice adjuvant therapy per standard of care.
Detailed description
A phase 2 open-label, randomized, multi-center trial to evaluate the efficacy and safety of neoadjuvant trastuzumab, pertuzumab and weekly paclitaxel (THP) as compared to neoadjuvant trastuzumab, pertuzumab, pembrolizumab and weekly paclitaxel (THP-pembrolizumab), or neoadjuvant trastuzumab, pembrolizumab and weekly paclitaxel (TH-pembrolizumab) in chemo naive patients with invasive human epidermal growth factor receptor 2 (HER2) positive breast cancer whose primary tumors are > 2 cm and/or clinically lymph node positive.
Patients will be randomized to either Arm A: THP (trastuzumab, pertuzumab and weekly paclitaxel), Arm B: THP-pembrolizumab (trastuzumab, pertuzumab, pembrolizumab) and weekly paclitaxel) or Arm C: TH-pembrolizumab (trastuzumab, pembrolizumab and weekly paclitaxel). Patients will be stratified according to hormone receptor status and lymph node status. All patients will be treated weekly every three weeks for four cycles (only paclitaxel will be administered weekly) and then undergo breast surgery. Arm A patients will be regarded as the reference group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1:1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Arm A: THP | Active comparator | Drug: Paclitaxel, Drug: Trastuzumab, Drug: PertuzumabArm A: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion. |
| Arm B: THP-Pembrolizumab | Experimental | Drug: Paclitaxel, Drug: Trastuzumab, Drug: Pertuzumab, Drug: PembrolizumabArm B: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab + Pembrolizumab All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion. |
| Arm C: TH-Pembrolizumab | Experimental | Drug: Paclitaxel, Drug: Trastuzumab, Drug: PembrolizumabArm C: Paclitaxel weekly x12 + Trastuzumab + Pembrolizumab All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male/female patients with histologically confirmed invasive HER2-positive (by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines) unilateral breast cancer
- Have previously untreated non-metastaic (M0), cT2-4N0 or cT1-4N1-3 (biopsies of clinically suspicious lymph nodes to confirm nodal status is encouraged).
- Multifocal/centric disease is permitted if all suspicious foci have been biopsied and are consistent with HER2-positive (by ASCO/CAP guidelines) invasive breast cancer
- Be a male or female subject 18 years of age on the day of signing informed consent
- Male Participants: A male participant must agree to use a contraception as detailed in Appendix C of this protocol during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period.
Key exclusion criteria (22 listed)
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.
- Has received prior therapy with an anti-PD-1 (programmed death protein 1), anti-PD-L1 (Programmed death-ligand 1), or anti PD L2 (Programmed death-ligand 2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization. Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
- Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
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 |
|---|---|---|
| PaclitaxelAlso: TaxolAll subjects will receive Paclitaxel weekly for 12 weeks | Drug | Arm A: THP, Arm B: THP-Pembrolizumab, Arm C: TH-Pembrolizumab |
| TrastuzumabAlso: HerceptinAll subjects will receive Trastuzumab every 3 weeks | Drug | Arm A: THP, Arm B: THP-Pembrolizumab, Arm C: TH-Pembrolizumab |
| PertuzumabAlso: PerjetaArm A and Arm B subjects will receive Pertuzumab every 3 weeks | Drug | Arm A: THP, Arm B: THP-Pembrolizumab |
| PembrolizumabAlso: KeytrudaArm B and Arm C subjects will receive Pembrolizumab every 3 weeks | Drug | Arm B: THP-Pembrolizumab, Arm C: TH-Pembrolizumab |
Primary outcome
Pathological Complete Response (pCR)
Time frame: 16 weeks from randomization
Proportion of subjects without residual invasive cancer in the breast and axilla from randomization to definitive surgery. - Residual invasive cancer defined based on hematoxylin and eosin evaluation of complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by pathologist assessment.
9 secondary outcomes
Pathological Complete Invasive and in Situ Response Rate (Breast and Axilla)
Time frame: 16 weeks from randomization
Pathological Complete Response Rate (pCR) in Breast Only
Time frame: 16 weeks from randomization
Residual Cancer Burden (RCB)
Time frame: 16 weeks from randomization
Breast Conserving Surgery Rate
Time frame: 16 weeks from randomization
Event Free Survival
Time frame: 36 months from randomization
Invasive Disease-free Survival (IDFS)
Time frame: 33 months from surgery
Overall Survival
Time frame: 36 months from randomization
Symptomatic Cardiac Events and Asymptomatic LVEF Events
Time frame: 36 months from randomization
AEs and SAEs
Time frame: 20 weeks from treatment initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Heather McArthur, MD principal investigator
University of Texas Southwestern Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel, Trastuzumab and Pertuzumab in people with HER2-positive Breast Cancer and Breast Cancer, run by University of Texas Southwestern Medical Center at 5 sites 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 17 inclusion and 22 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 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 8 May 2025). 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 Complete Response (pCR) (time frame: 16 weeks from randomization). 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 8 Jul 2026.