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NCT Number: NCT01142778

A Study of Bevacizumab Added to Trastuzumab Plus Docetaxel in the Neoadjuvant Setting in Participants With Early Stage HER2-Positive Breast Cancer

This randomized study will assess the effect of adding bevacizumab to trastuzumab plus docetaxel in neoadjuvant therapy in participants with early stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. After 2 cycles of trastuzumab and docetaxel once every 3 weeks, participants with a response (change in standard uptake value [SUV]) of less than (<) 70 percent (%) on Positron Emission Tomography (PET) will be randomized in a 2:1 ratio to receive Cycles 3 to 6 of trastuzumab (6 milligrams per kilogram [mg/kg]) and docetaxel (100 milligrams per square meter [mg/m^2]) with or without bevacizumab (15 mg/kg). Participants with a response of greater than or equal to (>/=) 70% will receive trastuzumab plus docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery (as per investigator's discretion) after Cycle 7 and between 4 and 6 weeks after the treatment perfusion of Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy (starting from 4-8 weeks after surgery during 4-6 weeks, according to site's standard practice) with or without hormonal therapy (mandatory if positive hormone receptors). Participants will be followed for up to 5 years from start of neoadjuvant treatment.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Centre Radiotherapie Marie Curie, Arras, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with early stage HER2-positive breast cancer
  • Scheduled to receive neoadjuvant therapy with the objective of conservative surgery
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

Exclusion criteria

  • Participants with partial or total lobular carcinoma
  • Participants with inflammatory breast cancer
  • Previous treatment with chemotherapy, radiation therapy or hormonal 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

Treatment and study plan

Bevacizumab

Drug

Bevacizumab at a dose of 15 mg/kg will be administered as IV infusion over 90 minutes from Cycles 3-6 (1 Cycle=21 days).

Other names: Avastin

docetaxel

Drug

Docetaxel at a dose of 100 mg/m^2 will be administered as IV infusion from Cycles 1-6 (1 Cycle=21 days).

Other names: Taxotere

Trastuzumab

Drug

Trastuzumab will be administered as a loading dose of 8 mg/kg as IV infusion in Cycle 1, followed by subsequent dose of 6 mg/kg as IV infusion in Cycles 2 to 7, and during additional 11 cycles post surgery (1 Cycle=21 days).

Other names: Herceptin

Surgery

Procedure

All participants will undergo surgery (as per investigator's discretion) after Cycle 7 and between 4 and 6 weeks after the study treatment infusion in Cycle 6 (1 Cycle=21 days).

Radiotherapy

Radiation

All participants will receive radiotherapy starting about 4 to 8 weeks after surgery, and will last around 4 to 6 weeks as per site's standard practice.

Hormonal therapy

Drug

Participants who are hormone receptors positive, will receive hormonal therapy after completion of radio therapy period as per investigator's discretion and site's standard practice.

Primary outcomes

  1. Percentage of Participants With Pathological Complete Response as per Chevallier's Classification as Reviewed by an Independent Committee

    Time frame: After 6 cycles (18 weeks) of neoadjuvant therapy (cycle length=21 days)

Secondary outcomes

  1. Percentage of Participants With Pathological Complete Response According to Chevallier's Classification as per Local Procedures

    Time frame: After 6 cycles (18 weeks) of neoadjuvant therapy (cycle length=21 days)

  2. Percentage of Participants With Pathological Complete Response According to Sataloff's Classification as Reviewed by an Independent Committee

    Time frame: After 6 cycles (18 weeks) of neoadjuvant therapy (cycle length=21 days)

  3. Percentage of Participants With Ultrasound Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)

    Time frame: Neodajuvant treatment period (21 weeks)

  4. Percentage of Participants With Conservative Surgery Post Neoadjuvant Treatment

    Time frame: Week 20 (between Day 28 and Day 35 after the Cycle 6, cycle length=21 days)

  5. Local Relapse-Free Interval (LRFI) According to Modified RECIST Criteria

    Time frame: From baseline to occurrence of relapse/disease or death of any cause (up to 5 years)

  6. Disease-Free Survival (DFS) According to Modified RECIST Criteria

    Time frame: From baseline to occurrence of relapse/disease or death of any cause (up to 5 years)

  7. Distant Disease-Free Interval (DDFI) According to Modified RECIST Criteria

    Time frame: From baseline to occurrence of relapse/disease or death of any cause (up to 5 years)

  8. Overall Survival

    Time frame: Baseline up to occurrence of death (up to 5 years)

  9. Percentage of Participants With Adverse Events

    Time frame: Baseline up to 5 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-Label, Randomized, Multicenter, Phase II, Non Comparative, Exploratory Study on Neoadjuvant Treatment With Trastuzumab Plus Docetaxel Plus Bevacizumab According to Positon Emission Tomography (PET) Value Modification in Patients With Early Stage HER2 Positive Breast Cancer

Acronym: AVATAXHER

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Jun 11, 2010
Registry last updated
Mar 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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