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Trial record 14 of 172 for:    pertuzumab

Safety Study of Pertuzumab (in Combination With Trastuzumab and Docetaxel) in Indian Participants With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02445586
Recruitment Status : Completed
First Posted : May 15, 2015
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a Phase 4, single-arm, open-label, multicenter study to assess the safety and efficacy of pertuzumab in combination with trastuzumab and docetaxel for the treatment of participants with human epidermal growth factor receptor 2 (HER2)-positive advanced (locally recurrent, unresectable, or metastatic) breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Docetaxel Drug: Pertuzumab Drug: Trastuzumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV, Multicenter, Open-Label, Single-Arm Study of Pertuzumab (in Combination With Trastuzumab and Docetaxel) in First Line Treatment of Indian Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer
Actual Study Start Date : August 17, 2015
Actual Primary Completion Date : September 26, 2018
Actual Study Completion Date : September 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Pertuzumab in Combination with Trastuzumab and Docetaxel
Participants will receive pertuzumab in combination with trastuzumab and docetaxel every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Drug: Docetaxel
Participants will receive docetaxel in line with locally approved Prescribing Information. After Cycle 6 (cycle length = 21 days), continuation of docetaxel treatment will be at the discretion of the investigator. Docetaxel will be administered after pertuzumab and trastuzumab.

Drug: Pertuzumab
Participants will receive pertuzumab at an initial dose of 840 milligrams (mg) as a 60-minute intravenous infusion on Cycle 1 Day 1 (cycle length = 21 days), followed by every 3 weeks at a dose of 420 mg as a 30 to 60-minute intravenous infusion until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Other Name: Perjeta®

Drug: Trastuzumab
Participants will receive trastuzumab at an initial dose of 8 milligrams per kilogram (mg/kg) as a 90-minute intravenous infusion on Cycle 1 Day 1 (cycle length = 21 days), followed by every 3 weeks at a dose of 6 mg/kg as a 30 to 90-minute intravenous infusion until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Other Names:
  • Herceptin®
  • Herclon®




Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to approximately 3 years ]
  2. Percentage of Participants with Congestive Heart Failure (CHF) and/or Significant Decline in Left Ventricular Ejection Fraction (LVEF) [ Time Frame: Baseline up to approximately 3 years ]
  3. Change from Baseline in LVEF at Year 3 as Determined by Either Echocardiogram (ECHO) or Multigated Acquisition (MUGA) Scan [ Time Frame: Baseline, Year 3 ]

Secondary Outcome Measures :
  1. Percentage of Participants with Objective Response of Complete Response (CR) or Partial Response (PR) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Screening (Day -7 to -1) up to disease progression or death (assessed at every 9 weeks, up to approximately 3 years) ]
  2. Progression-Free Survival (PFS) Using RECIST Version 1.1 [ Time Frame: Screening (Day -7 to -1) up to disease progression or death (assessed at every 9 weeks, up to approximately 3 years) ]
  3. Overall Survival (OS) [ Time Frame: Baseline up to death (assessed up to approximately 3 years) ]


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

Inclusion Criteria:

  • For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly-effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and/or partner
  • Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection; participants with measurable and/or non-measurable disease are eligible
  • Known and documented HER2-positive
  • Known and documented LVEF of at least 50 percent (%)
  • Adequate organ function
  • A negative serum beta-human chorionic gonadotropin (beta-HCG) test for women of childbearing potential (premenopausal, or less than [<] 12 months of amenorrhea post-menopause, and women who have not undergone surgical sterilization [absence of ovaries and/or uterus]) within 7 days prior to the first dose of study treatment with the result available prior to first dosing

Exclusion Criteria:

  • Previous systemic non-hormonal anti-cancer therapy for the metastatic or locally recurrent disease
  • Pregnant or lactating women
  • Current clinical or radiographic evidence of central nervous system (CNS) metastases
  • Disease progression while receiving or within 12 months of completion of trastuzumab and/or lapatinib treatment in the adjuvant or neo-adjuvant setting
  • History of LVEF decline to below 50% during or after prior trastuzumab adjuvant or neo-adjuvant therapy

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): NCT02445586


Locations
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India
Rajiv Gandhi Cancer Institute & Research Center
New Delhi, Delhi, India, 110 085
Tata Memorial Hospital; Dept of Medical Oncology
Mumbai, Maharashtra, India, 400012
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
Mumbai, Maharashtra, India, 400053
Jehangir Clinical Development Centre Pvt. Ltd; Cancer Research Room
Pune, Maharashtra, India, 411001
Christian Medical College & Hospital; Medicine
Vellore, Tamil NADU, India, 632004
Indo-American Cancer Hospital & Research Center
Hyderabad, Telangana, India, 500034
TATA Medical Centre; Medical Oncology
Kolkata, WEST Bengal, India, 700156
M S Ramaiah Memorial Hospital
Bangalore, India, 560054
MAX Balaji Hospital
Delhi, India, 110092
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Anil Kukreja, MD Roche Products (India) Pvt. Ltd.

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02445586     History of Changes
Other Study ID Numbers: ML29282
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pertuzumab
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Trastuzumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological