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

Metastatic HER2-Positive Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02252887
• Other study ID #: 14-124
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 12, 2015
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic HER2-Positive Breast Cancer

Intervention

Drug:
• Gemcitabine

• Trastuzumab

• Pertuzumab

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering at Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Hartford Healthcare Cancer Institute @ Hartford Hospital	Hartford	Connecticut
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Genentech, Inc., Hartford HealthCare, Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	3 months
Secondary	progression-free survival	Progression-free survival (PFS) is defined from time from treatment assignment to disease progression or death, whichever comes first.	2 years
Secondary	response	Response to treatment will be determined using both RECIST and PRC ( PET Response Criteria criteria).	2 years
Secondary	overall survival	Progression-free survival and median overall survival will also be estimated by the Kaplan-Meier method.	2 years
Secondary	safety	This study will use the NCI Common Toxicity Criteria (CTC) AE version 4.0 for toxicity.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center