Trial Outcomes & Findings for Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab, or Pertuzumab Based Therapy (NCT NCT02252887)

Last Updated: 2026-07-24

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

3 months

Results posted on

2026-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	Gemcitabine, Trastuzumab, and Pertuzuma 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. Gemcitabine Trastuzumab Pertuzumab
Overall Study STARTED	45
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Reasons for withdrawal
Measure	Gemcitabine, Trastuzumab, and Pertuzuma 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. Gemcitabine Trastuzumab Pertuzumab
Overall Study Death	1
Overall Study Physician Decision	2
Overall Study Withdrawal by Subject	1
Overall Study Progression of disease	36

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine, Trastuzumab, and Pertuzuma n=45 Participants 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. Gemcitabine Trastuzumab Pertuzumab
Age, Continuous	57.1 years n=9 Participants
Sex: Female, Male Female	45 Participants n=9 Participants
Sex: Female, Male Male	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	4 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	6 Participants n=9 Participants
Race (NIH/OMB) White	32 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=9 Participants
Region of Enrollment United States	45 Participants n=9 Participants

PRIMARY outcome

Timeframe: 3 months

Population: At 3 months 12 participants are evaluable

Outcome measures

Outcome measures
Measure	Gemcitabine, Trastuzumab, and Pertuzuma n=12 Participants 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. Gemcitabine Trastuzumab Pertuzumab
Progression Free	73.3 percentage of participants Interval 61.5 to 87.5

SECONDARY outcome

Timeframe: 2 years

Progression-free survival (PFS) is defined from time from treatment assignment to disease progression or death, whichever comes first.

Outcome measures

Outcome measures
Measure	Gemcitabine, Trastuzumab, and Pertuzuma n=45 Participants 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. Gemcitabine Trastuzumab Pertuzumab
Progression-free Survival	5.5 months Interval 5.4 to 8.2

SECONDARY outcome

Timeframe: 3 months

Response to treatment will be determined using both RECIST and PRC ( PET Response Criteria criteria).

Outcome measures

Outcome measures
Measure	Gemcitabine, Trastuzumab, and Pertuzuma n=45 Participants 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. Gemcitabine Trastuzumab Pertuzumab
Response Complete Response	1 Participants
Response Partial Response	9 Participants
Response Stable Disease	23 Participants
Response Progression of Disease	11 Participants
Response Not Evaluable	1 Participants

SECONDARY outcome

Timeframe: 3 months

Progression-free survival and median overall survival will also be estimated by the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Gemcitabine, Trastuzumab, and Pertuzuma n=45 Participants 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. Gemcitabine Trastuzumab Pertuzumab
Overall Survival Survival at 3 months	44 Participants
Overall Survival Not Evaluable	1 Participants

SECONDARY outcome

Timeframe: 2 years

This study will use the NCI Common Toxicity Criteria (CTC) AE version 4.0 for toxicity. Grade 3 or higher AEs

Outcome measures

Outcome measures
Measure	Gemcitabine, Trastuzumab, and Pertuzuma n=45 Participants 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. Gemcitabine Trastuzumab Pertuzumab
Number of Participants With Grade 3+ Adverse Events Neutropenia	23 Participants
Number of Participants With Grade 3+ Adverse Events Anemia	6 Participants
Number of Participants With Grade 3+ Adverse Events alanine aminotransferase level elevation	2 Participants
Number of Participants With Grade 3+ Adverse Events aspartate transaminase level elevation	1 Participants
Number of Participants With Grade 3+ Adverse Events fatigue	1 Participants
Number of Participants With Grade 3+ Adverse Events thrombocytopenia	1 Participants
Number of Participants With Grade 3+ Adverse Events diarrhea	1 Participants
Number of Participants With Grade 3+ Adverse Events nausea	1 Participants

Adverse Events

Gemcitabine, Trastuzumab, and Pertuzuma

Serious events: 8 serious events

Other events: 45 other events

Deaths: 20 deaths

Serious adverse events

Serious adverse events
Measure	Gemcitabine, Trastuzumab, and Pertuzuma n=45 participants at risk 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. Gemcitabine Trastuzumab Pertuzumab
Gastrointestinal disorders Nausea	2.2% 1/45 • 2 years
General disorders Pain	2.2% 1/45 • 2 years
Eye disorders Photophobia	2.2% 1/45 • 2 years
Vascular disorders Thromboembolic Event	2.2% 1/45 • 2 years
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.2% 1/45 • 2 years
Injury, poisoning and procedural complications Hip fracture	2.2% 1/45 • 2 years
Cardiac disorders Atrial Fibrillation	4.4% 2/45 • 2 years
General disorders Fever	2.2% 1/45 • 2 years
Nervous system disorders Headache	4.4% 2/45 • 2 years
Infections and infestations Lung Infection	2.2% 1/45 • 2 years
Gastrointestinal disorders Gastrointestinal disorders	2.2% 1/45 • 2 years
Respiratory, thoracic and mediastinal disorders Cough	2.2% 1/45 • 2 years
Respiratory, thoracic and mediastinal disorders Dyspnea	2.2% 1/45 • 2 years
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.2% 1/45 • 2 years
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	2.2% 1/45 • 2 years
Musculoskeletal and connective tissue disorders Back pain	2.2% 1/45 • 2 years
Eye disorders Eye pain	2.2% 1/45 • 2 years

Other adverse events

Other adverse events
Measure	Gemcitabine, Trastuzumab, and Pertuzuma n=45 participants at risk 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. Gemcitabine Trastuzumab Pertuzumab
General disorders Fatigue	93.3% 42/45 • 2 years
Blood and lymphatic system disorders Anemia	86.7% 39/45 • 2 years
Blood and lymphatic system disorders Neutropenia	71.1% 32/45 • 2 years
Blood and lymphatic system disorders Thrombocytopenia	64.4% 29/45 • 2 years
Nervous system disorders Peripheral neuropathy	64.4% 29/45 • 2 years
Investigations ALT level elevation	60.0% 27/45 • 2 years
Investigations AST level elevation	51.1% 23/45 • 2 years
Gastrointestinal disorders Diarrhea	46.7% 21/45 • 2 years
Gastrointestinal disorders Nausea	46.7% 21/45 • 2 years
Investigations Alkaline phosphatase level elevation	40.0% 18/45 • 2 years
Respiratory, thoracic and mediastinal disorders Cough	35.6% 16/45 • 2 years
Musculoskeletal and connective tissue disorders Myalgia	28.9% 13/45 • 2 years
Musculoskeletal and connective tissue disorders Arthralgia	26.7% 12/45 • 2 years
Respiratory, thoracic and mediastinal disorders Dyspnea	24.4% 11/45 • 2 years

Additional Information

Dr. Chau Dang, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-888-5426

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place