Metastatic HER2-Positive Breast CancerPhase 2NCT02252887

Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab, or Pertuzumab Based Therapy

A Phase 2 study testing Gemcitabine, Trastuzumab and Pertuzumab in people with Metastatic HER2-Positive Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Metastatic HER2-Positive Breast Cancer
What is being tested?: Gemcitabine, Trastuzumab and Pertuzumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 5 sitesUnited States
Study dates: 12 Jan 2015to 24 Jul 2025
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

Age ≥ to 18
Stage IV HER2 (+) breast cancer
Histologically documented HER2 (+) breast cancer as defined as IHC 3+ or FISH amplification of ≥ 2.0 of primary or metastatic site; results from the local lab are acceptable.
lECOG performance status 0 -1
Prior treatment with trastuzumab + pertuzumab (HP)-based therapy or pertuzumab-based in the neoadjuvantadjuvant, unresectable, locally advanced, or metastatic setting.
≤ 3 prior chemotherapies in the metastatic setting. Prior anthracycline, taxane, gemcitabine, and anti-HER2 agents (i.e. trastuzumab, pertuzumab, lapatinib, neratinib, TDM-1, etc.) are allowed. If patients received prior gemcitabine, it could not have been combined with pertuzumab. Patients should have progression of disease on current therapy.

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Measurable or non-measurable disease.
LVEF ≥ 50%
Hematologic parameters: white blood cell (WBC) count of ≥ 3000/ul, absolute neutrophil count (ANC) ≥ 1000/ul, platelets ≥ 100,000/ul, hemoglobin ≥10.0 g/dl
Non-hematologic parameters: bilirubin ≤ 1.5 mg/dl, AST/ALT≤ 2.5 x upper limit of normal (ULN), alkaline phosphatase ≤ 5 x ULN.
Creatinine ≤ 1.5 mg/dl
Patients with "treated and stable" brain lesions of a duration of ≥ 2 months may be enrolled.

Who cannot join

History of prior unstable angina, myocardial infarction, CHF, uncontrolled ventricular arrhythmias within 12 months
History of prior ≥ G 3 hypersensitivity (HSR) or any toxicity to trastuzumab or pertuzumab that warranted permanent cessation of this agent
History of hepatitis B or C
Pregnant patients

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, 06102
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center
New York, New York, 10065

Other trials in United States

About this study

Official title: Phase II Study of Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab- or Pertuzumab-Based Therapy

The purpose of this study is to see if a combination of drugs can help to treat breast cancer. This is a Phase II study which will test whether this combination of drugs is effective and will provide further information on side effects and safety. A standard chemotherapy, gemcitabine, will be combined with 2 other drugs that target the HER2 receptor. The HER2 receptor is a growth protein on the surface of some breast cancer cells that provides messages telling the breast cancer cell to grow. The standard chemotherapy will be gemcitabine.. The other two drugs work against HER2. One is called trastuzumab (Herceptin) and it is commonly given to women with advanced and early HER2 positive breast cancer. The other drug, pertuzumab (Perjeta), is also given to women with advanced HER2 positive breast cancer. The drugs in this study are each individually approved for the treatment of metastatic breast cancer. However, this study is looking at the effectiveness of gemcitabine with trastuzumab and pertuzumab when given to women who have advanced HER2 positive breast cancer who have had prior trastuzumab + pertuzumab or pertuzumab-based therapy.

Conditions: Metastatic HER2-Positive Breast Cancer
Being tested: Gemcitabine, Trastuzumab, Pertuzumab
Keywords: Gemcitabine,, Trastuzumab, Pertuzumab, 14-124

What participants receive

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

Study groups in NCT02252887
Study group	Role	What they receive
Gemcitabine, Trastuzumab, and Pertuzuma	Experimental	The regimen will consist of gemcitabine at 1000mg/m^2 IV weekly days 1 + 8 q 3 weeks + trastuzumab every 3 weeks (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) + pertuzumab every 3 weeks (840 mg as a loading dose followed by 420 mg every 3 weeks), all given intravenously (IV). Trastuzumab may be given IV weekly (4 mg/kg loading dose followed by 2 mg/kg weekly) in lieu of the every 3 week schedule. A loading dose of trastuzumab will not be required for patients who have received it < 6 weeks prior to Cycle 1 Day 1. Receives: Drug: Gemcitabine; Drug: Trastuzumab; Drug: Pertuzumab

What is being measured

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

Progression Free
Progression-free survival (PFS) is defined from time from treatment assignment to disease progression or death, whichever comes first. The primary endpoint is PFS and secondary endpoint will include the response rate using the RECIST criteria (version 1.1).
Measured: 3 months

Secondary outcomes (4)

Progression-free Survival
Progression-free survival (PFS) is defined from time from treatment assignment to disease progression or death, whichever comes first.
Measured: 2 years
Response
Response to treatment will be determined using both RECIST and PRC ( PET Response Criteria criteria).
Measured: 3 months
Overall Survival
Progression-free survival and median overall survival will also be estimated by the Kaplan-Meier method.
Measured: 3 months
Number of Participants With Grade 3+ Adverse Events
This study will use the NCI Common Toxicity Criteria (CTC) AE version 4.0 for toxicity. Grade 3 or higher AEs
Measured: 2 years

Timeline

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

12 Jan 201524 Jul 2025

First posted30 Sep 2014 (estimated)
Study start12 Jan 2015
Primary completion24 Jul 2025
Study completion24 Jul 2025

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metastatic HER2-Positive Breast CancerStudies of the same condition, open and under way.
More trials run by Memorial Sloan Kettering Cancer 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02252887
Sponsor's protocol ID: 14-124
Status last verified: Jul 2025
First submitted: 26 Sep 2014
Last updated: 24 Jul 2026
Results posted: Yes, on ClinicalTrials.gov

Publications

Iyengar NM, Smyth LM, Lake D, Gucalp A, Singh JC, Traina TA, DeFusco P, Fornier MN, Goldfarb S, Jhaveri K, Modi S, Troso-Sandoval T, Patil S, Ulaner GA, Jochelson M, Norton L, Hudis CA, Dang CT. Efficacy and Safety of Gemcitabine With Trastuzumab and Pertuzumab After Prior Pertuzumab-Based Therapy Among Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer: A Phase 2 Clinical Trial. JAMA Netw Open. 2019 Nov 1;2(11):e1916211. doi: 10.1001/jamanetworkopen.2019.16211.
PubMed 31774522

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study of Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab- or Pertuzumab-Based Therapy
ClinicalTrials.gov ID: NCT02252887
Acronym / sponsor ID: 14-124
Conditions: Metastatic HER2-Positive Breast Cancer
Keywords: Gemcitabine,, Trastuzumab, Pertuzumab, 14-124
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
Collaborators: Genentech, Inc., Hoffmann-La Roche, Hartford HealthCare
Study start: 12 Jan 2015 (actual)
Primary completion: 24 Jul 2025 (actual)
Study completion: 24 Jul 2025 (actual)
First posted: 30 Sep 2014 (estimated)
Results: Posted 24 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Gemcitabine, Trastuzumab, and Pertuzuma	Experimental	Drug: Gemcitabine, Drug: Trastuzumab, Drug: PertuzumabThe regimen will consist of gemcitabine at 1000mg/m^2 IV weekly days 1 + 8 q 3 weeks + trastuzumab every 3 weeks (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) + pertuzumab every 3 weeks (840 mg as a loading dose followed by 420 mg every 3 weeks), all given intravenously (IV). Trastuzumab may be given IV weekly (4 mg/kg loading dose followed by 2 mg/kg weekly) in lieu of the every 3 week schedule. A loading dose of trastuzumab will not be required for patients who have received it < 6 weeks prior to Cycle 1 Day 1.

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)

Age ≥ to 18
Stage IV HER2 (+) breast cancer
Histologically documented HER2 (+) breast cancer as defined as IHC 3+ or FISH amplification of ≥ 2.0 of primary or metastatic site; results from the local lab are acceptable.
lECOG performance status 0 -1
Prior treatment with trastuzumab + pertuzumab (HP)-based therapy or pertuzumab-based in the neoadjuvantadjuvant, unresectable, locally advanced, or metastatic setting.

Key exclusion criteria (4 listed)

History of prior unstable angina, myocardial infarction, CHF, uncontrolled ventricular arrhythmias within 12 months
History of prior ≥ G 3 hypersensitivity (HSR) or any toxicity to trastuzumab or pertuzumab that warranted permanent cessation of this agent
History of hepatitis B or C
Pregnant patients

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
Gemcitabine	Drug	Gemcitabine, Trastuzumab, and Pertuzuma
Trastuzumab	Drug	Gemcitabine, Trastuzumab, and Pertuzuma
Pertuzumab	Drug	Gemcitabine, Trastuzumab, and Pertuzuma

Primary outcome

Progression Free
Time frame: 3 months
Progression-free survival (PFS) is defined from time from treatment assignment to disease progression or death, whichever comes first. The primary endpoint is PFS and secondary endpoint will include the response rate using the RECIST criteria (version 1.1).

4 secondary outcomes

Progression-free Survival
Time frame: 2 years
Response
Time frame: 3 months
Overall Survival
Time frame: 3 months
Number of Participants With Grade 3+ Adverse Events
Time frame: 2 years

Results and safety

Results posted to the registry on 24 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gemcitabine, Trastuzumab, and Pertuzuma	45	5

Primary outcome: Progression Free

Time frame: 3 months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Gemcitabine, Trastuzumab, and Pertuzuma n = 12
Value	73.3 (61.5 to 87.5)

Population analysed: At 3 months 12 participants are evaluable

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gemcitabine, Trastuzumab, and Pertuzuma	8 of 45 (17.8%)	45 of 45 (100%)	20 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31774522Iyengar NM, Smyth LM, Lake D, Gucalp A, Singh JC, Traina TA, DeFusco P, Fornier MN, Goldfarb S, Jhaveri K, Modi S, Troso-Sandoval T, Patil S, Ulaner GA, Jochelson M, Norton L, Hudis CA, Dang CT. Efficacy and Safety of Gemcitabine With Trastuzumab and Pertuzumab After Prior Pertuzumab-Based Therapy Among Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer: A Phase 2 Clinical Trial. JAMA Netw Open. 2019 Nov 1;2(11):e1916211. doi: 10.1001/jamanetworkopen.2019.16211.
Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.

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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.

Chau Dang, MD principal investigator

Memorial Sloan Kettering Cancer 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 Gemcitabine, Trastuzumab and Pertuzumab in people with Metastatic HER2-Positive Breast Cancer, run by Memorial Sloan Kettering Cancer 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 12 inclusion and 4 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: finished, as of the sponsor's last update on 24 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 24 Jul 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?

Progression Free (time frame: 3 months). 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 NCT02252887, which also lists 1 linked publication.

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 24 Jul 2026.