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HER2-positive Breast CancerPhase 2NCT03125928

Clinical Trial of Atezolizumab With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer

A Phase 2 study testing Atezolizumab, Paclitaxel and Trastuzumab in people with HER2-positive Breast Cancer, run by Fox Chase Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a single arm, Phase IIA clinical trial assessing the safety and efficacy of atezolizumab in combination with paclitaxel, trastuzumab, and pertuzumab in 50 patients with locally advanced, unresectable, or metastatic HER2-overexpressing breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
HER2-positive Breast Cancer
What is being tested?
Atezolizumab, Paclitaxel and Trastuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
13 Jun 2017to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Women diagnosed with pathologically confirmed HER2-overexpressing breast cancer, that is locally recurrent, unresectable or metastatic (negative or positive for ER/PR, and positive for HER2).
  • HER2 status confirmed positive by means of immunohistochemistry (IHC) or in situ hybridization (ISH) according to ASCO/CAP 2013 guidelines. It is considered positive if scored as 3+ by an IHC method defined as uniform membrane staining for HER2 in 10% or more of tumor cells or demonstrate HER2 gene amplification by an ISH method (single probe, average HER2 copy number ≥ 6.0 signals/cell; dual probe HER2/CEP17 ratio ≥2.0 with an average HER2 copy number ≥4.0 signals/cell; dual probe HER2/chromosome enumeration probe (CEP)17 ratio ≥2.0 with an average HER2 copy number <4.0 signals/cell; HER2/CEP17 ratio <2.0 with an average HER2 copy number ≥ 6.0 signals/cell).
  • Have measurable clinical disease: Measurable disease, defined as at least 1 measurable lesion on a CT scan as defined by RECIST (version v1.1).
  • Age > 18 years.
  • ECOG performance status 0,1or 2.
  • Adequate organ function (defined by the following parameters): Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Hemoglobin ≥ 10 g/dL.Platelets ≥ 100 x 109/L. Serum bilirubin ≤ 1.5 x upper normal limit (UNL), except patients with Gilbert's syndrome. Serum alanine aminotransferase (ALT) ≤ 2 x UNL or ≤ 5.0 x UNL in case of liver metastases. Serum aspartate aminotransferase (AST) ≤ 2 x UNL or ≤ 5.0 x UNL in case of liver metastases. Serum creatinine < 140 μmol/L (< 1.6 mg/dL) or 1.5x the upper limit of normal, whichever is less. Serum alkaline phosphatase (ALP) ≤ UNL or ≤ 2.5 x ULN in case of liver and bone metastases.
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  • Left ventricular ejection fraction of 50% or more at baseline (by echocardiography or multiple-gated acquisition scanning).
  • Patients may have received one prior hormonal treatment for metastatic disease.
  • Patients may have received adjuvant or neoadjuvant chemotherapy with or without trastuzumab and pertuzumab with an interval greater than than 12 months since completion of adjuvant/neoadjuvant treatment.
  • Ability to understand and willingness to sign a written informed consent and HIPAA consent document.
  • Female participants of childbearing age must be willing to use contraception methods, or abstain from sexual activity throughout the course of the study and for 7 months after the last dose of atezolizumab.
  • Have provided tissue from a newly obtained biopsy obtained from a focus of metastatic disease, and be willing to consider repeat biopsy post-treatment after at least 4 cycles of treatment (an archival tissue sample may be substituted if new biopsy cannot be obtained and by discretion of Sponsor Investigator).

Who cannot join

  • Patients participating in another trial of an investigational agent within 4 weeks of the 1st dose of the study.
  • Patients with tumors that cannot be measured or clinically followed.
  • Patients who had received therapy for metastatic breast cancer (other than that described above).
  • Patients with active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 4 weeks prior to trial treatment.
  • Patients with any baseline grade 2 neuropathy.
  • Patients with known prior hypersensitivity reaction to any of the study drugs.
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  • Active autoimmune disease that is requiring systemic treatment within the past 3 months or documented history of clinically active autoimmune disease that requires systemic corticosteroids or immunosuppressive therapy.
  • Diagnosis of immunosuppression or receiving steroid therapy or other immunosuppressive therapy within 4 weeks of the study.
  • Have evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Patients with human immunodeficiency virus (HIV1/2). An HIV test must be performed to confirm status prior to enrollment.
  • Patients who are carriers of hepatitis virus B and C. Hepatitis B and C testing must be performed to confirm status prior to enrollment.
  • Prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death 1 ligand (PDL-1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte -associated antigen-4 (CTLA-4) antibody.
  • Pregnant, breastfeeding, or expecting to conceive within the projected time of the trial, starting with the pre-screening or screening visit and through 7 months after the last dose of trial treatment.
  • Active infection requiring systemic therapy.
  • Active substance abuse or psychiatric disorders.
  • The use of a RANKL inhibitor (denosumab) must be discontinued during the study. Bisphosphonate therapy is permitted.
  • The following treatments must be discontinued: Herbal Medications. Immunomodulatory agents, including but not limited to interferons or IL-2. Immunosuppressive medications, including but not limited to cyclophosphamide, azathioprine, methotrexate, and thalidomide. Systemic corticosteroids. Anti-TNF-α agents.
  • Any live, attenuated vaccine within 28 days prior to the first day of treatment or during study treatment, or unwillingness to avoid live, attenuated vaccines within 90 days following the last dose of atezolizumab.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

Other trials in United States

About this study

Official title: Single Arm, Phase IIA Clinical Trial Assessing The Safety And Efficacy of Atezolizumab in Combination With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer

This is a single arm, Phase IIA clinical trial assessing the safety and efficacy of atezolizumab in combination with paclitaxel, trastuzumab, and pertuzumab in 50 patients with locally advanced, unresectable, or metastatic HER2-overexpressing breast cancer. Due to concerns that corticosteroids may have a negative effect on tumor immunity expected with addition of atezolizumab to the standard of care regimen, patients will receive premedication with dexamethasone only for weeks 1 and 2 of the weekly paclitaxel, and then corticosteroid premedication will be discontinued subsequently.

Patients must have pathologically confirmed HER2-overexpressing breast cancer that is locally recurrent, unresectable, or metastatic, with measurable disease as defined by RECIST v1.1. Tumor measurements and bone scans will be performed every 9 weeks while patients are on study.

Keywords
Atezolizumab, PD-L1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03125928
Study groupRoleWhat they receive
Investigational ArmExperimentalNot described
Receives: Drug: Atezolizumab; Drug: Paclitaxel; Drug: Trastuzumab; Drug: Pertuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-related adverse events

    Treatment-related adverse events will be assessed by CTCAE v4.0

    Measured: Up to 5 years after stopping study treatment

  2. Antitumor activity of atezolizumab plus the standard regimen of paclitaxel, trastuzumab, and pertuzumab

    Antitumor activity will be measured by RECIST v1.1

    Measured: An average of 18 weeks

Secondary outcomes (11)

  1. Overall survival (OS)

    OS is defined as the time from initiation of treatment until death from any cause or end of the study period, whichever occurs first.

    Measured: Up to 5 years after the last patient stops treatment

  2. Time to tumor progression (TTP)

    TTP is defined as the duration of time from the start of treatment to the first objectively documented instance of progressive disease.

    Measured: Up to 5 years after the last patient stops treatment

  3. Time to treatment failure (TTF)

    TTF is defined as the duration of time from start of treatment to discontinuation of study treatment for reasons defined in the protocol.

    Measured: Up to 5 years after the last patient stops treatment

  4. Progression free survival (PFS)

    PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

    Measured: Up to 5 years after the last patient stops treatment

  5. Clinical benefit rate (CBR)

    CBR is defined as the rates of complete response (CR), partial response (PR) and stable disease (SD).

    Measured: Up to 5 years after the last patient stops treatment

  6. Duration of response (DOR)

    Per RECIST v1.1, DOR will be assessed by the duration of overall response, duration fo CR/PR, and duration of SD.

    Measured: Up to 5 years after the last patient stops treatment

  7. Correlation of biomarkers related to PD-L1 blockade with objective response rate (ORR), CBR, PFS, OS, and DOR.

    Efficacy will be assessed according to tumor PD-L1 expression level and tumor infiltrating lymphocytes PD-L1 expression levels.

    Measured: Up to 5 years after the last patient stops treatment

  8. Efficacy according to hormone receptor status (ER/PR)

    This will be a future subset analysis.

    Measured: Up to 5 years after the last patient stops treatment

  9. Feasibility of discontinuation of corticosteroids use after 2 weekly doses of paclitaxel

    This will be assessed by CTCAE v4.0.

    Measured: Up to 5 years after the last patient stops treatment

  10. Rate of occurrence of paclitaxel-related infusion hypersensitivity reaction after discontinuation of corticosteroids

    This will be assessed by CTCAE v4.0.

    Measured: An average of 18 weeks

  11. Cardiac safety

    Quarterly MUGA or ECHO results assessing occurrence of left ventricular dysfunction.

    Measured: An average of 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2017
  2. Study start13 Jun 2017
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03125928
Sponsor's protocol ID
BR-093
Other IDs
17-1010
Status last verified
May 2026
First submitted
22 Mar 2017
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab, Paclitaxel and Trastuzumab in people with HER2-positive Breast Cancer, run by Fox Chase Cancer Center 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 18 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 22 May 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?

This study is still under way. Results are not available in the source record yet.

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?

Number of participants with treatment-related adverse events (time frame: Up to 5 years after stopping study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03125928.

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 22 May 2026.

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