A Study of Pertuzumab in Addition to Chemotherapy and Herceptin (Trastuzumab) as Adjuvant Therapy in Patients With HER2-Positive Primary Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Genentech, Inc.
Breast International Group
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01358877
First received: May 20, 2011
Last updated: October 20, 2014
Last verified: October 2014

May 20, 2011
October 20, 2014
November 2011
December 2023   (final data collection date for primary outcome measure)
Invasive disease-free survival (IDFS) [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01358877 on ClinicalTrials.gov Archive Site
  • IDFS including second non-breast cancer [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
  • Disease-free survival (DFS), including second non-breast cancer or contralateral or ipsilateral ductal carcinoma in situ [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
  • Recurrence-free interval (RFI): time between randomization and local, regional or distant breast cancer recurrence [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
  • Distant recurrence-free interval (DRFI): time between randomization and distant breast cancer recurrence [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
  • Cardiac and overall safety: Incidence of adverse events [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
  • Quality of life: EORTC QLQ-C30, QLQ-BR23 and EQ-5D questionnaires [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Pertuzumab in Addition to Chemotherapy and Herceptin (Trastuzumab) as Adjuvant Therapy in Patients With HER2-Positive Primary Breast Cancer
A Randomized Multicenter, Double-blind, Placebo-controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-positive Primary Breast Cancer

This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus Herceptin (t rastuzumab) as adjuvant therapy in patients with operable HER2-positive primary breast cancer. After surgery, patients will be randomized to receive either pert uzumab or placebo intravenously (iv) every 3 weeks for one year, in addition to 6-8 cycles of chemotherapy and 1 year of Herceptin (trastuzumab) iv every 3 wee ks. Anticipated time on study treatment is 52 weeks. This study will be carried out in collaboration with the Breast International Group (BIG).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Chemotherapy
    6-8 cycles of standard chemotherapy (non-anthracycline based or anthracycline-based)
  • Drug: pertuzumab
    840 mg iv loading dose in Cycle 1, followed by 420 mg iv every 3 weeks, 52 weeks
  • Drug: placebo
    iv every 3 weeks, 52 weeks
  • Drug: trastuzumab [Herceptin]
    8 mg/kg iv loading dose in Cycle 1, followed by 6 mg/kg iv every 3 weeks, 52 weeks
  • Experimental: 1
    Interventions:
    • Drug: Chemotherapy
    • Drug: pertuzumab
    • Drug: trastuzumab [Herceptin]
  • Placebo Comparator: 2
    Interventions:
    • Drug: Chemotherapy
    • Drug: placebo
    • Drug: trastuzumab [Herceptin]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4808
December 2023
December 2023   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients. >/= 18 years of age
  • Non-metastatic primary invasive HER2-positive carcinoma of the breast that is adequately excised and that is node-positive (except T0)
  • Eastern Cooperative Oncology Group (ECOG) performance status </=1
  • The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy must be administered within 7 days of randomization or on Day 56, whichever occurs first.
  • Known hormone receptor status (estrogen receptor and progesterone receptor)
  • Baseline LVEF >/= 55%
  • Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the patient and/or partner for the duration of the study treatment and for at least 6 months after the last dose of study drug

Exclusion Criteria:

  • History of any prior (ipsi- and/or contralateral) invasive breast cancer
  • History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
  • Any "clinical" T4 tumor as defined by TNM, including inflammatory breast cancer
  • Any previous systemic chemotherapy for cancer or radiotherapy for cancer
  • Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
  • Concurrent anti-cancer treatment in another investigational trial
  • Serious cardiac or cardiovascular disease or condition
  • Pregnant or lactating women
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan,   United States,   Argentina,   Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Croatia,   Czech Republic,   Denmark,   El Salvador,   France,   Germany,   Guatemala,   Hong Kong,   Hungary,   Ireland,   Israel,   Italy,   United Kingdom,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Panama,   Peru,   Philippines,   Poland,   Romania,   Russian Federation,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Ukraine
 
NCT01358877
BO25126, TOC4939G, 2010-022902-41, BIG 04-11
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
  • Genentech, Inc.
  • Breast International Group
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP