A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545688
First received: October 16, 2007
Last updated: August 19, 2014
Last verified: August 2014

October 16, 2007
August 19, 2014
June 2006
September 2014   (final data collection date for primary outcome measure)
Pathological complete response rate [ Time Frame: Post-surgery ] [ Designated as safety issue: No ]
Pathological complete response rate post-surgery.
Complete list of historical versions of study NCT00545688 on ClinicalTrials.gov Archive Site
  • Disease-free interval, PFS, breast-conserving surgery rate. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, LVEF [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Efficacy:Disease free interval, progression free survival, breast conserving surgery rate. Safety:AEs, lab parameters, LVEF.
Not Provided
Not Provided
 
A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.
A Randomized, Open Label Study to Compare the Complete Pathological Response Rate Achieved With 4 Combinations of Herceptin, Docetaxel and Pertuzumab in Patients With Locally Advanced, Inflammatory or Early Stage HER2 Positive Breast Cancer

This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatmen t regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin

  • docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-w eekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and doceta xel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The an ticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: pertuzumab
    840mg iv loading dose, followed by 420mg iv 3-weekly
  • Drug: Herceptin
    8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly
  • Drug: docetaxel
    75mg/m2 iv escalating to 100mg/m2 iv 3-weekly
  • Experimental: 1
    Interventions:
    • Drug: Herceptin
    • Drug: docetaxel
  • Experimental: 2
    Interventions:
    • Drug: pertuzumab
    • Drug: Herceptin
    • Drug: docetaxel
  • Experimental: 3
    Interventions:
    • Drug: pertuzumab
    • Drug: Herceptin
  • Experimental: 4
    Interventions:
    • Drug: pertuzumab
    • Drug: docetaxel
Gianni L, Pienkowski T, Im YH, Roman L, Tseng LM, Liu MC, Lluch A, Staroslawska E, de la Haba-Rodriguez J, Im SA, Pedrini JL, Poirier B, Morandi P, Semiglazov V, Srimuninnimit V, Bianchi G, Szado T, Ratnayake J, Ross G, Valagussa P. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012 Jan;13(1):25-32. doi: 10.1016/S1470-2045(11)70336-9. Epub 2011 Dec 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
417
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • female patients, >=18 years of age;
  • locally advanced, inflammatory or early stage invasive breast cancer;
  • HER2 positive (HER2+++ by IHC or FISH/CISH+).

Exclusion Criteria:

  • metastatic disease (Stage IV) or bilateral breast cancer;
  • previous anticancer therapy or radiotherapy for any malignancy;
  • other malignancy, other than cancer in situ of the cervix, or basal cell cancer;
  • insulin-dependent diabetes;
  • clinically relevant cardiovascular disease.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Brazil,   Canada,   Israel,   Italy,   Korea, Republic of,   Mexico,   Peru,   Poland,   Russian Federation,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   United Kingdom
 
NCT00545688
WO20697
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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