A Study of Avastin (Bevacizumab) Added to Herceptin (Trastuzumab) Plus Docetaxel in the Neoadjuvant Setting in Patients With Early Stage HER2-Positive Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01142778
First received: June 10, 2010
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This randomized, open-label study will assess the effect of adding Avastin (beva cizumab) to Herceptin (trastuzumab) plus docetaxel in neoadjuvant therapy in pat ients with early stage HER2-positive breast cancer. After 2 cycles of Herceptin and docetaxel once every 3 weeks, patients with a response of <70% on Positron E mission Tomography will be randomized 2:1 to receive cycles 3 to 6 of Herceptin (6mg/kg iv) and docetaxel (100mg/m2 iv) with or without Avastin (15mg/kg iv). Pa tients with a response of >/=70% will receive Herceptin plus docetaxel for cycle s 3 to 6. After surgery, all patients will receive a further 12 cycles of Hercep tin plus standard of care treatment and will be followed for up to 5 years. Anti cipated time on study treatment is 18 weeks.


Condition Intervention Phase
Breast Cancer
Drug: bevacizumab [Avastin]
Drug: docetaxel
Drug: trastuzumab [Herceptin]
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pathological complete response (according to Chevalier criteria, reviewed by independent committee) [ Time Frame: after 6 cycles (18 weeks) of neoadjuvant therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ultrasound response rate (according to RECIST criteria) [ Time Frame: after 6 cycles (18 weeks) of neoadjuvant treatment ] [ Designated as safety issue: No ]
  • Rate of conservative surgery [ Time Frame: after 6 cycles (18 weeks) of neoadjuvant treatment ] [ Designated as safety issue: No ]
  • Relapse/disease-free survival [ Time Frame: from baseline to occurrence of relapse/disease or death of any cause (up to 5 years) ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: from baseline to death of any cause (up to 5 years) ] [ Designated as safety issue: No ]
  • Safety: Adverse events [ Time Frame: throughout study (up to 5 years) ] [ Designated as safety issue: No ]

Enrollment: 152
Study Start Date: May 2010
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: bevacizumab [Avastin]
15mg/kg iv, cycles 3-6
Drug: docetaxel
100mg/m2 iv, cycles 1-6
Drug: trastuzumab [Herceptin]
8mg/kg iv cycle 1, 6mg/kg iv cycles 2-6; plus an additional 12 cycles post surgery
Active Comparator: B Drug: docetaxel
100mg/m2 iv, cycles 1-6
Drug: trastuzumab [Herceptin]
8mg/kg iv cycle 1, 6mg/kg iv cycles 2-6; plus an additional 12 cycles post surgery

  Eligibility

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

Inclusion Criteria:

  • female patients, >/=18 years of age
  • early stage HER2-positive breast cancer
  • scheduled to receive neoadjuvant therapy with the objective of conservative surgery
  • ECOG performance status 0, 1 or 2

Exclusion Criteria:

  • partially or totally lobular carcinoma
  • inflammatory breast cancer
  • bifocal and/or bilateral tumour
  • metastases
  • previous treatment with chemotherapy, radiation therapy or hormone therapy for breast cancer
  • previous history of cancer (other than curatively treated basal and squamous cell carcinoma of the skin and/or in situ carcinoma of the cervix) relapsing within the 5 years before study entry or in situ contralateral breast carcinoma
  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: NCT01142778

Locations
France
Arras, France, 62000
Beauvais, France, 60021
Bordeaux, France, 33000
Brest, France, 29200
Clermont Ferrand, France, 63011
Clermont Ferrand, France, 63050
Dijon, France, 21079
Grenoble, France, 38000
La Roche Sur Yon, France, 85925
Limoges, France, 87042
Lyon, France, 69373
Metz, France, 57072
Montlucon, France, 03100
Montpellier, France, 34298
Nancy, France, 54100
Nice, France, 06189
Paris, France, 75970
Paris, France, 75674
Paris, France, 75231
Perigueux, France, 24000
Reims CEDEX, France, 51056
Rennes, France, 35042
Saint Jean, France, 31240
St Priest En Jarez, France, 42271
Strasbourg, France, 67065
Toulouse, France, 31076
Tours, France, 37044
Vandoeuvre Les Nancy, France, 54511
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: NCT01142778     History of Changes
Other Study ID Numbers: ML22229, 2009-013410-26
Study First Received: June 10, 2010
Last Updated: August 26, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Docetaxel
Trastuzumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014