Trial Outcomes & Findings for Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) (NCT NCT06136897)

Last Updated: 2025-12-05

Results Overview

ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

Tumor assessments occurred at baseline, then every 3 cycles for the first 33 cycles, and every 4 cycles thereafter until disease progression, up to 3 years post registration

Results posted on

2025-12-05

Participant Flow

Subprotocol J was activated on March 13, 2017. Thirty-five patients were enrolled between March 2017 and June 2019. Eleven patients were enrolled on the basis of the results from the NCI-MATCH assay and 24 on the basis of the outside assay results.

Patients with HER2 amplification as established in the analytical assay (CN ≥7) detected by NGS, were considered for the Arm J subprotocol. The mutation status was determined by an NCI-MATCH approved laboratory for 24 patients in this arm, these cases had to be confirmed to be used in primary analysis.

Participant milestones

Participant milestones
Measure	Treatment (Pertuzumab, Trastuzumab) Patients receive pertuzumab IV over 30-60 minutes and trastuzumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Pertuzumab was administered before trastuzumab each cycle; 840 mg loading dose and 420 mg thereafter. Trastuzumab loading dose was 8 mg/kg then 6 mg/kg thereafter. Patients also undergo radiologic evaluation throughout the trial, ECHO at screening and end of treatment, and biopsy and collection of blood samples on trial and at end of treatment.
Overall Study STARTED	35
Overall Study Started Protocol Therapy	35
Overall Study Eligible and Treated	32
Overall Study Eligible, Treated and Mutation Status Confirmed	25
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Pertuzumab, Trastuzumab) Patients receive pertuzumab IV over 30-60 minutes and trastuzumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Pertuzumab was administered before trastuzumab each cycle; 840 mg loading dose and 420 mg thereafter. Trastuzumab loading dose was 8 mg/kg then 6 mg/kg thereafter. Patients also undergo radiologic evaluation throughout the trial, ECHO at screening and end of treatment, and biopsy and collection of blood samples on trial and at end of treatment.
Overall Study Ineligible	3
Overall Study Mutation status not confirmed	7
Overall Study Adverse Event	2
Overall Study Death	1
Overall Study Disease progression	18
Overall Study Other complicating disease	1
Overall Study Withdrawal by Subject	1
Overall Study Still on treatment	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Pertuzumab, Trastuzumab) n=25 Participants Patients receive pertuzumab IV over 30-60 minutes and trastuzumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Pertuzumab was administered before trastuzumab each cycle; 840 mg loading dose and 420 mg thereafter. Trastuzumab loading dose was 8 mg/kg then 6 mg/kg thereafter. Patients also undergo radiologic evaluation throughout the trial, ECHO at screening and end of treatment, and biopsy and collection of blood samples on trial and at end of treatment.
Age, Continuous	66 years n=37 Participants
Sex: Female, Male Female	14 Participants n=37 Participants
Sex: Female, Male Male	11 Participants n=37 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=37 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=37 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants
Race (NIH/OMB) Asian	0 Participants n=37 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants
Race (NIH/OMB) Black or African American	3 Participants n=37 Participants
Race (NIH/OMB) White	22 Participants n=37 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants

PRIMARY outcome

Timeframe: Tumor assessments occurred at baseline, then every 3 cycles for the first 33 cycles, and every 4 cycles thereafter until disease progression, up to 3 years post registration

Population: Eligible, treated and mutation status confirmed

Outcome measures

Outcome measures
Measure	Treatment (Pertuzumab, Trastuzumab) n=25 Participants Patients receive pertuzumab IV over 30-60 minutes and trastuzumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Pertuzumab was administered before trastuzumab each cycle; 840 mg loading dose and 420 mg thereafter. Trastuzumab loading dose was 8 mg/kg then 6 mg/kg thereafter. Patients also undergo radiologic evaluation throughout the trial, ECHO at screening and end of treatment, and biopsy and collection of blood samples on trial and at end of treatment.
Objective Response Rate	12 percentage of participants Interval 3.4 to 28.2

SECONDARY outcome

Timeframe: Tumor assessments occurred at baseline, then every 3 cycles for the first 33 cycles, and every 4 cycles thereafter until disease progression, up to 3 years post registration

Population: Eligible, treated and mutation status confirmed

Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point.

Outcome measures

Outcome measures
Measure	Treatment (Pertuzumab, Trastuzumab) n=25 Participants Patients receive pertuzumab IV over 30-60 minutes and trastuzumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Pertuzumab was administered before trastuzumab each cycle; 840 mg loading dose and 420 mg thereafter. Trastuzumab loading dose was 8 mg/kg then 6 mg/kg thereafter. Patients also undergo radiologic evaluation throughout the trial, ECHO at screening and end of treatment, and biopsy and collection of blood samples on trial and at end of treatment.
6-month Progression-Free Survival (PFS) Rate	25.3 percentage of participants Interval 10.7 to 40.0

SECONDARY outcome

Timeframe: Tumor assessments occurred at baseline, then every 3 cycles for the first 33 cycles, and every 4 cycles thereafter until disease progression, up to 3 years post registration

Population: Eligible, treated and mutation status confirmed

PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression.

Outcome measures

Outcome measures
Measure	Treatment (Pertuzumab, Trastuzumab) n=25 Participants Patients receive pertuzumab IV over 30-60 minutes and trastuzumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Pertuzumab was administered before trastuzumab each cycle; 840 mg loading dose and 420 mg thereafter. Trastuzumab loading dose was 8 mg/kg then 6 mg/kg thereafter. Patients also undergo radiologic evaluation throughout the trial, ECHO at screening and end of treatment, and biopsy and collection of blood samples on trial and at end of treatment.
Progression Free Survival	3.3 months Interval 2.0 to 4.1

Adverse Events

Treatment (Pertuzumab, Trastuzumab)

Serious events: 9 serious events

Other events: 27 other events

Deaths: 27 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Pertuzumab, Trastuzumab) n=35 participants at risk Patients receive pertuzumab IV over 30-60 minutes and trastuzumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO at screening and end of treatment, and biopsy and collection of blood samples on trial and at end of treatment.
Cardiac disorders Heart failure	5.7% 2/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
General disorders Fatigue	2.9% 1/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
General disorders Infusion related reaction	2.9% 1/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Gastrointestinal disorders Abdominal pain	2.9% 1/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	2.9% 1/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Investigations Alkaline phosphatase increased	2.9% 1/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Investigations Lymphocyte count decreased	2.9% 1/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Metabolism and nutrition disorders Hypophosphatemia	2.9% 1/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Nervous system disorders Stroke	2.9% 1/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.9% 1/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.9% 1/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Vascular disorders Hypertension	2.9% 1/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Vascular disorders Hypotension	2.9% 1/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.

Other adverse events

Other adverse events
Measure	Treatment (Pertuzumab, Trastuzumab) n=35 participants at risk Patients receive pertuzumab IV over 30-60 minutes and trastuzumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO at screening and end of treatment, and biopsy and collection of blood samples on trial and at end of treatment.
Blood and lymphatic system disorders Anemia	14.3% 5/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Cardiac disorders Sinus tachycardia	5.7% 2/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
General disorders Chills	11.4% 4/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
General disorders Fatigue	20.0% 7/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
General disorders Fever	5.7% 2/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
General disorders Infusion related reaction	25.7% 9/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Skin and subcutaneous tissue disorders Dry skin	5.7% 2/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Skin and subcutaneous tissue disorders Pruritus	11.4% 4/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	5.7% 2/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Gastrointestinal disorders Constipation	8.6% 3/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Gastrointestinal disorders Diarrhea	31.4% 11/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Gastrointestinal disorders Nausea	14.3% 5/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Gastrointestinal disorders Vomiting	8.6% 3/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Investigations Alanine aminotransferase increased	5.7% 2/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Investigations Alkaline phosphatase increased	14.3% 5/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Investigations Aspartate aminotransferase increased	8.6% 3/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Investigations Lymphocyte count decreased	8.6% 3/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Investigations Platelet count decreased	8.6% 3/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Investigations Weight loss	5.7% 2/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Metabolism and nutrition disorders Anorexia	14.3% 5/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Metabolism and nutrition disorders Hypoalbuminemia	11.4% 4/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Metabolism and nutrition disorders Hypokalemia	5.7% 2/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Metabolism and nutrition disorders Hypomagnesemia	14.3% 5/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Metabolism and nutrition disorders Hyponatremia	5.7% 2/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Metabolism and nutrition disorders Hypophosphatemia	5.7% 2/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Nervous system disorders Dysgeusia	5.7% 2/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.
Vascular disorders Hypertension	5.7% 2/35 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 patients were included in the all-cause mortality and toxicity analysis.

Additional Information

Study Statistician

ECOG-ACRIN Cancer Research Group

Phone: 617-632-3012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60