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A Study Comparing Kadcyla Plus Perjeta Treatment to Chemotherapy Combined With Herceptin Plus Perjeta in Patients With HER2-Positive Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02131064
First received: May 2, 2014
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

In this randomized, multicenter, open-label, two-arm study, Kadcyla (trastuzumab emtansine) plus Perjeta (pertuzumab) will be compared to chemotherapy plus Herc eptin (trastuzumab) plus Perjeta in the treatment of operable HER2-positive brea st cancer. Patients will be randomized in a 1: 1 ratio to receive either of the following neoadjuvant treatments for a total of six 3-week cycles: Arm A: Docet axel + carboplatin + Herceptin + Perjeta Arm B: Kadcyla + Perjeta Following tr eatment, patients will undergo surgery. After recovery, patients will be given t he following adjuvant treatment: Arm A: Herceptin + Perjeta Arm B: Kadcyla + P erjeta Treatment can be stopped due to disease recurrence, unacceptable toxicit y, withdrawal of consent, or study termination. Study is expected to last approx imately 45 months.


Condition Intervention Phase
Breast Cancer
Drug: carboplatin
Drug: docetaxel
Drug: pertuzumab [Perjeta]
Drug: trastuzumab emtansine [Kadcyla]
Drug: trastuzumab [Herceptin]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A RANDOMIZED, MULTICENTER, OPEN-LABEL, TWO-ARM, PHASE III NEOADJUVANT STUDY EVALUATING TRASTUZUMAB EMTANSINE PLUS PERTUZUMAB COMPARED WITH CHEMOTHERAPY PLUS TRASTUZUMAB AND PERTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Local evaluation of pathological complete response (pCR) [ Time Frame: Approximately 21 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Event-free survival (EFS) [ Time Frame: Approximately 36 months ] [ Designated as safety issue: No ]
  • Invasive disease-free survival (IDFS) [ Time Frame: Approximately 36 months ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Approximately 36 months ] [ Designated as safety issue: No ]
  • Breast-conserving surgery rate [ Time Frame: Approximately 36 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Approximately 36 months ] [ Designated as safety issue: No ]
  • Incidence of hepatic events [ Time Frame: Approximately 36 months ] [ Designated as safety issue: No ]
  • Incidence of cardiac events [ Time Frame: Approximately 36 months ] [ Designated as safety issue: No ]
  • Health related quality of life as assessed by the European organization for reasearch and treatment of cancer (EORTC) quality of life questionnaire (QLQ) C30/BR23 [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
  • Observed drug serum concentrations [ Time Frame: Up to 20 months ] [ Designated as safety issue: No ]
  • Incidence of anti-therapeutic antibodies [ Time Frame: Up to 20 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 432
Study Start Date: June 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Herceptin (trastuzumab) + Perjeta (pertuzumab) + Chemotherapy Drug: carboplatin
Given IV at a dose eliciting an area under the concentration-time curve (AUC) of 6
Drug: docetaxel
75 mg/m2 given IV every 3 weeks
Drug: pertuzumab [Perjeta]
420 mg given IV every 3 weeks (840 mg loading dose)
Drug: trastuzumab [Herceptin]
6 mg/kg given IV every 3 weeks (8 mg/kg loading dose)
Experimental: Kadcyla (trastuzumab emtansine) + Perjeta (pertuzumab) Drug: pertuzumab [Perjeta]
420 mg given IV every 3 weeks (840 mg loading dose)
Drug: trastuzumab emtansine [Kadcyla]
3.6 mg/kg given as an intravenous (IV) infusion every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age >/= 18 years
  • Histologically confirmed invasive breast cancer with a primary tumor size of > 2 cm
  • HER2-positive breast cancer
  • Patients with multifocal tumors (more than one tumor confined to the same quadrant as the primary tumor) if all sampled lesions are centrally confirmed as HER2-positive
  • Stage at presentation: cT2 cT4, cN0 cN3, cM0
  • Known hormone receptor status of the primary tumor
  • Patient agreement to undergo mastectomy or breast-conserving surgery after neoadjuvant therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Baseline LVEF >55% measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA)
  • Effective contraception as defined by protocol

Exclusion Criteria:

  • Stage IV (metastatic) breast cancer
  • Patients who have received prior anti-cancer therapy for breast cancer except those patients with a history of breast lobular carcinoma in situ (LCIS) that was surgically managed or ductal carcinoma in situ (DCIS) treated exclusively with mastectomy. In case of prior history of LCIS/DCIS, >5 years must have passed from surgery until diagnosis of current breast cancer
  • Patients with multicentric (multiple tumors involving more than 1 quadrant) or bilateral breast cancer
  • Patients who have undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
  • Axillary lymph node dissection or positive sentinel lymph node prior to start of neoadjuvant therapy.
  • History of concurrent or previous non-breast malignancies except for appropriately treated (1) non-melanoma skin cancer and (2) in situ carcinomas, including cervix, colon, and skin. A patient with previous invasive non-breast cancer is eligible provided he/she has been disease-free >/= 5 years
  • Treatment with any investigational drug within 28 days prior to randomization
  • Current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 Grade >/= 2 peripheral neuropathy
  • Any significant concurrent medical or surgical conditions or findings that would jeopardize the patient's safety or ability to complete the study
  • Pregnancy or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02131064

Contacts
Contact: Reference Study ID Number: BO28408 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 84 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02131064     History of Changes
Other Study ID Numbers: BO28408
Study First Received: May 2, 2014
Last Updated: November 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Ado-trastuzumab emtansine
Maytansine
Pertuzumab
Trastuzumab
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 19, 2014