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Trial record 1 of 1 for:    BO28407
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A Study of Kadcyla (Trastuzumab Emtansine) Plus Perjeta (Pertuzumab) Following Anthracyclines in Comparison With Herceptin (Trastuzumab) Plus Perjeta and a Taxane Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary 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:
NCT01966471
First received: October 17, 2013
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

This two-arm, randomized, open-label, multicenter study will evaluate the effica cy and safety of Kadcyla (trastuzumab emtansine, also known as T-DM1) in combina tion with Perjeta (pertuzumab) versus Herceptin (trastuzumab) in combination wit h Perjeta and a taxane as adjuvant therapy in patients with HER2-positive primar y invasive breast cancer. Following surgery and anthracycline-based chemotherapy

, patients will receive either Kadcyla 3.6 mg/kg and Perjeta 420 mg intravenousl y (iv) every three weeks or Herceptin 6 mg/kg iv every three weeks in combinatio n with Perjeta and a taxane. Anticipated time on HER2 targeted study treatment i s up to 1 year.


Condition Intervention Phase
Breast Cancer
Drug: anthracycline-based chemotherapy
Drug: pertuzumab [Perjeta]
Drug: taxane
Drug: trastuzumab [Herceptin]
Drug: trastuzumab emtansine [Kadcyla]
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, PHASE III TRIAL COMPARING TRASTUZUMAB PLUS PERTUZUMAB PLUS A TAXANE FOLLOWING ANTHRACYCLINES VERSUS TRASTUZUMAB EMTANSINE PLUS PERTUZUMAB FOLLOWING ANTHRACYCLINES AS ADJUVANT THERAPY IN PATIENTS WITH OPERABLE HER2-POSITIVE PRIMARY BREAST CANCER

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Invasive disease-free survival (IDFS), defined as time from randomization to occurrence of ipsilateral breast cancer recurrence, second primary invasive breast cancer, distant recurrence, or death of any cause [ Time Frame: up to approximately 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IDFS plus second primary non-breast cancer, excluding non-melanoma skin cancers and carcinoma in situ of any site [ Time Frame: up to approximately 10 years ] [ Designated as safety issue: No ]
  • Disease-free survival (DFS), defined as time between randomization and first occurrence of IDFS, second primary non-breast cancer and contralateral or ipsilateral ductal carcinoma in situ (DCIS) [ Time Frame: up to approximately 10 years ] [ Designated as safety issue: No ]
  • Distant recurrence-free interval (DRFI), defined as time between randomization and first occurrence of distant breast cancer recurrence [ Time Frame: up to approximately 10 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to approximately 10 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to approximately 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: January 2014
Estimated Study Completion Date: January 2024
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Herceptin + Pertuzumab + Taxane Drug: anthracycline-based chemotherapy
3 to 4 cycles of standard of care anthracycline-based chemotherapy
Drug: pertuzumab [Perjeta]
840 mg loading dose followed by 420 mg IV q3w
Drug: taxane
paclitaxel 80 mg/m2 IV qw or docetacel q3w
Drug: trastuzumab [Herceptin]
8 mg/kg loading dose followed by 6 mg/kg IV q3w
Experimental: Kadcyla + Pertuzumab Drug: anthracycline-based chemotherapy
3 to 4 cycles of standard of care anthracycline-based chemotherapy
Drug: pertuzumab [Perjeta]
840 mg loading dose followed by 420 mg IV q3w
Drug: trastuzumab emtansine [Kadcyla]
3.6 mg/kg IV q3w

  Eligibility

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

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status </= 1
  • Non-metastatic histologically confirmed primary invasive breast carcinoma that was operable
  • HER2-positive breast cancer
  • Known hormone receptor status of the primary tumor
  • Adequately excised: patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
  • Pathological tumor-node-metastasis staging (Union for International Cancer Control-American Joint Committee on Cancer [UICC/AJCC] 7th edition): Eligible patients must have either:

Node-positive disease (pN >/= 1), any tumor size except T0, and any hormonal receptor status, or Node-negative disease (pN0) with pathologic tumor size >2.0 cm by standard local assessment AND negative for ER and PR determined by a central pathology laboratory

  • Patients with synchronous bilateral invasive disease are eligible only if both lesions are HER2 positive
  • No more than 9 weeks (63 days) may elapse between definitive breast surgery (or the last surgery if additional resection required for breast cancer) and randomization
  • Baseline LVEF >/= 55% measured by echocardiogram (ECHO; preferred) or multiple-gated acquisition (MUGA) scans
  • Documentation on hepatitis B virus (HBV) and hepatitic C virus (HCV) serologies is required
  • Female patients of childbearing potential must be willing to use one highly effective form of nonhormonal contraception or two effective forms of nonhormonal contraception. For male patients with partners of childbearing potential, one highly effective form of contraception or two effective forms of contraception must be used. Contraception must continue for the duration of study treatment and for 6 months after the last dose of study treatment

Exclusion Criteria:

  • History of any prior (ipsilateral and/or contralateral) invasive breast carcinoma
  • History of non-breast malignancies within the 5 years prior to randomization, except for carcinoma in situ (CIS) of the cervix, CIS of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
  • Any clinical T4 tumor as defined by tumor-node-metastasis classification in UICC/AJCC 7th edition, including inflammatory breast cancer
  • For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy (e.g., trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, OR anti-cancer radiation therapy (RT) (intraoperative radiotherapy as a boost at the time of primary surgery is acceptable)
  • Previous therapy with anthracyclines, taxanes, or HER2-targeted therapy for any malignancy
  • History of DCIS and/or LCIS that was treated with any form of systemic chemotherapy, hormonal therapy, or RT to the ipsilateral breast where invasive cancer subsequently developed. Patients who had their DCIS/LCIS treated with surgery only and/or contralateral DCIS treated with radiation are allowed to enter the study
  • Patients with contraindication to RT while adjuvant RT is clinically indicated
  • Concurrent anti-cancer treatment in another investigational trial
  • Cardiopulmonary dysfunction as defined by protocol
  • Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease
  • Significant symptoms (Grade >/=2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia
  • Myocardial infarction within 12 months prior to randomization
  • Uncontrolled hypertension
  • Evidence of transmural infarction on ECG
  • Requirement for oxygen therapy
  • Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes, or known infection with HIV
  • Any known active liver disease. For patients who are known carriers of HBV/HCV, active hepatitis B/C infection must be ruled out per local guidelines.
  • Inadequate hematologic, renal or liver function
  • Pregnant or lactating women
  • Hypersensitivity to any of the study medications or any of the ingredients or excipients of these medications, including hypersensitivity to benzyl alcohol
  • Chronic immunosuppressive therapies, including systemic corticosteroids
  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: NCT01966471

Contacts
Contact: Reference Study ID Number: BO28407 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 344 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: NCT01966471     History of Changes
Other Study ID Numbers: BO28407, 2012-004902-82
Study First Received: October 17, 2013
Last Updated: November 24, 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
Taxane
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 24, 2014