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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 ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: May 2, 2014
Last updated: August 1, 2016
Last verified: August 2016

In this randomized, multicenter, open-label, two-arm study, Kadcyla (trastuzumab emtansine) plus Perjeta (pertuzumab) will be compared to chemotherapy plus Herceptin (trastuzumab) plus Perjeta in the treatment of operable HER2-positive breast 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: Docetaxel + carboplatin + Herceptin + Perjeta Arm B: Kadcyla + Perjeta

Following treatment, patients will undergo surgery. After recovery, patients will be given the following adjuvant treatment:

Arm A: Herceptin + Perjeta Arm B: Kadcyla + Perjeta Treatment can be stopped due to disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination. Study is expected to last approximately 45 months.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

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 ]

Secondary Outcome Measures:
  • Event-free survival (EFS) [ Time Frame: Approximately 36 months ]
  • Invasive disease-free survival (IDFS) [ Time Frame: Approximately 36 months ]
  • Overall survival (OS) [ Time Frame: Approximately 36 months ]
  • Breast-conserving surgery rate [ Time Frame: Approximately 36 months ]
  • Incidence of adverse events [ Time Frame: Approximately 36 months ]
  • Incidence of hepatic events [ Time Frame: Approximately 36 months ]
  • Incidence of cardiac events [ Time Frame: Approximately 36 months ]
  • 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 ]
  • Observed drug serum concentrations [ Time Frame: Up to 20 months ]
  • Incidence of anti-therapeutic antibodies [ Time Frame: Up to 20 months ]

Enrollment: 444
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


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

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 identifier: NCT02131064

  Show 79 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT02131064     History of Changes
Other Study ID Numbers: BO28408
Study First Received: May 2, 2014
Last Updated: August 1, 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Ado-trastuzumab emtansine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic processed this record on April 27, 2017