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History of Changes for Study: NCT02131064
A Study Comparing Kadcyla Plus Perjeta Treatment to Chemotherapy Combined With Herceptin Plus Perjeta in Patients With HER2-Positive Breast Cancer
Latest version (submitted June 25, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 2, 2014 None (earliest Version on record)
2 May 19, 2014 Contacts/Locations and Study Status
3 May 26, 2014 Contacts/Locations and Study Status
4 June 23, 2014 Recruitment Status, Study Status, Contacts/Locations and Study Description
5 June 30, 2014 Oversight and Study Status
6 July 7, 2014 Study Status and Contacts/Locations
7 July 14, 2014 Contacts/Locations and Study Status
8 July 21, 2014 Contacts/Locations and Study Status
9 July 28, 2014 Contacts/Locations and Study Status
10 August 4, 2014 Study Status and Contacts/Locations
11 August 19, 2014 Contacts/Locations and Study Status
12 August 26, 2014 Study Status
13 September 22, 2014 Study Status
14 October 6, 2014 Study Status
15 October 13, 2014 Contacts/Locations and Study Status
16 October 20, 2014 Contacts/Locations and Study Status
17 November 3, 2014 Contacts/Locations and Study Status
18 November 10, 2014 Contacts/Locations and Study Status
19 November 17, 2014 Contacts/Locations and Study Status
20 November 24, 2014 Contacts/Locations and Study Status
21 December 1, 2014 Study Status
22 December 8, 2014 Contacts/Locations and Study Status
23 December 15, 2014 Contacts/Locations and Study Status
24 December 23, 2014 Contacts/Locations and Study Status
25 December 29, 2014 Contacts/Locations and Study Status
26 January 6, 2015 Study Status and Contacts/Locations
27 January 19, 2015 Contacts/Locations and Study Status
28 February 5, 2015 Contacts/Locations, Study Status, Eligibility and Study Description
29 February 19, 2015 Contacts/Locations and Study Status
30 February 23, 2015 Contacts/Locations and Study Status
31 March 2, 2015 Study Status
32 March 9, 2015 Contacts/Locations and Study Status
33 March 23, 2015 Contacts/Locations and Study Status
34 April 2, 2015 Contacts/Locations and Study Status
35 May 5, 2015 Study Status
36 May 11, 2015 Contacts/Locations and Study Status
37 May 29, 2015 Contacts/Locations and Study Status
38 June 1, 2015 Study Status
39 July 1, 2015 Recruitment Status, Study Status, Contacts/Locations and Study Design
40 August 17, 2015 Study Status
41 September 1, 2015 Contacts/Locations and Study Status
42 September 9, 2015 Contacts/Locations and Study Status
43 October 1, 2015 Study Status and Contacts/Locations
44 November 2, 2015 Study Status and Contacts/Locations
45 December 1, 2015 Study Status
46 December 31, 2015 Study Status
47 February 1, 2016 Study Status and Contacts/Locations
48 March 1, 2016 Study Status
49 April 2, 2016 Study Status
50 May 4, 2016 Study Status
51 June 1, 2016 Contacts/Locations and Study Status
52 July 1, 2016 Study Status
53 August 1, 2016 Study Status
54 May 9, 2017 Study Status, Outcome Measures, Arms and Interventions, Study Identification, Results, Contacts/Locations, Eligibility, Conditions and Study Description
55 August 29, 2017 Study Status, Arms and Interventions and Contacts/Locations
56 November 21, 2017 Study Status and Contacts/Locations
57 April 25, 2018 Study Status and Contacts/Locations
58 July 31, 2018 Recruitment Status, Study Status and Contacts/Locations
59 September 20, 2018 Study Status
60 June 25, 2019 Outcome Measures, Adverse Events, Participant Flow, Study Status, Baseline Characteristics, Contacts/Locations, More Information and Oversight
Comparison Format:
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Study NCT02131064
Submitted Date:  May 2, 2014 (v1)
Open or close this module Study Identification
Unique Protocol ID: BO28408
Brief Title: A Study Comparing Kadcyla Plus Perjeta Treatment to Chemotherapy Combined With Herceptin Plus Perjeta in Patients With HER2-Positive Breast Cancer
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
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2014
Overall Status: Not yet recruiting
Study Start: June 2014
Primary Completion: September 2018 [Anticipated]
Study Completion: September 2018 [Anticipated]
First Submitted: May 2, 2014
First Submitted that
Met QC Criteria:		 May 2, 2014
First Posted: May 6, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:		 May 2, 2014
Last Update Posted: May 6, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Hoffmann-La Roche
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

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.
Detailed Description:
Open or close this module Conditions
Conditions: Breast Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 432 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Kadcyla (trastuzumab emtansine) + Perjeta (pertuzumab) Drug: trastuzumab emtansine [Kadcyla]
3.6 mg/kg given as an intravenous (IV) infusion every 3 weeks
Drug: pertuzumab [Perjeta]
420 mg given IV every 3 weeks (840 mg loading dose)
Active Comparator: Herceptin (trastuzumab) + Perjeta (pertuzumab) + Chemotherapy 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)
Drug: docetaxel
75 mg/m2 given IV every 3 weeks
Drug: carboplatin
Given IV at a dose eliciting an area under the concentration-time curve (AUC) of 6
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Local evaluation of pathological complete response (pCR)
[ Time Frame: Approximately 21 months ]
Secondary Outcome Measures:
1. Event-free survival (EFS)
[ Time Frame: Approximately 36 months ]
2. Invasive disease-free survival (IDFS)
[ Time Frame: Approximately 36 months ]
3. Overall survival (OS)
[ Time Frame: Approximately 36 months ]
4. Breast-conserving surgery rate
[ Time Frame: Approximately 36 months ]
5. Incidence of adverse events
[ Time Frame: Approximately 36 months ]
6. Incidence of hepatic events
[ Time Frame: Approximately 36 months ]
7. Incidence of cardiac events
[ Time Frame: Approximately 36 months ]
8. 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 ]
9. Observed drug serum concentrations
[ Time Frame: Up to 20 months ]
10. Incidence of anti-therapeutic antibodies
[ Time Frame: Up to 20 months ]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Reference Study ID Number: BO28408 www.roche.com/about_roche/roche_worldwide.htm
Telephone: 888-662-6728 (U.S. Only)
Email: global.rochegenentechtrials@roche.com
Study Officials: Clinical Trials
Study Director
Hoffmann-La Roche
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services