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

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ClinicalTrials.gov Identifier: NCT02252887
Recruitment Status : Active, not recruiting
First Posted : September 30, 2014
Last Update Posted : October 2, 2019
Sponsor:
Collaborators:
Genentech, Inc.
Hoffmann-La Roche
Hartford HealthCare
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic HER2-Positive Breast Cancer Drug: Gemcitabine Drug: Trastuzumab Drug: Pertuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 12, 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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.
Drug: Gemcitabine
Drug: Trastuzumab
Drug: Pertuzumab



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: 2 years ]
    Progression-free survival (PFS) is defined from time from treatment assignment to disease progression or death, whichever comes first.

  2. response [ Time Frame: 2 years ]
    Response to treatment will be determined using both RECIST and PRC ( PET Response Criteria criteria).

  3. overall survival [ Time Frame: 2 years ]
    Progression-free survival and median overall survival will also be estimated by the Kaplan-Meier method.

  4. safety [ Time Frame: 2 years ]
    This study will use the NCI Common Toxicity Criteria (CTC) AE version 4.0 for toxicity.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252887


Locations
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United States, Connecticut
Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, New Jersey
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
United States, New York
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Genentech, Inc.
Hoffmann-La Roche
Hartford HealthCare
Investigators
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Principal Investigator: Chau Dang, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02252887     History of Changes
Other Study ID Numbers: 14-124
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Keywords provided by Memorial Sloan Kettering Cancer Center:
Gemcitabine,
Trastuzumab
Pertuzumab
14-124
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Trastuzumab
Pertuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological