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

NCT00545688

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Breast Cancer

Interventions: Herceptin, Docetaxel, Pertuzumab

Countries: Australia, Austria, Brazil, Canada, Israel, Italy, Mexico, Peru

This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment 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-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel 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 anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (77)
  • Geelong, Victoria, Australia
  • Perth, Western Australia, Australia
  • Vienna, Austria
  • Vienna, Austria
  • Ijuí, Rio Grande do Sul, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Itajaí, Santa Catarina, Brazil
  • Jaú, São Paulo, Brazil
  • Santo André, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • Sorocaba, São Paulo, Brazil
  • Moncton, New Brunswick, Canada
  • Kingston, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Québec, Canada
  • Jerusalem, Israel
  • Kfar Saba, Israel
  • Tel Aviv, Israel
  • Bologna, Emilia-Romagna, Italy
  • Parma, Emilia-Romagna, Italy
  • Udine, Friuli Venezia Giulia, Italy
  • Legnano, Lombardy, Italy
  • Milan, Lombardy, Italy
  • Milan, Lombardy, Italy
  • Mirano, Veneto, Italy
  • Santorso, Veneto, Italy
  • Vicenza, Veneto, Italy
  • + 47 more on CT.gov