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Breast CancerPhase 2NCT00717405

A Study of Avastin (Bevacizumab) Plus Herceptin (Trastuzumab) in Patients With Primary Inflammatory HER2-Positive Breast Cancer.

A Phase 2 study testing Standard chemotherapy, bevacizumab [Avastin] and trastuzumab [Herceptin] in people with Breast Cancer, run by Hoffmann-La Roche at 28 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Standard chemotherapy, bevacizumab [Avastin] and trastuzumab [Herceptin]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
28 sitesFrance
Study dates
Oct 2008to Oct 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult females, >=18 years of age;
  • inflammatory breast cancer;
  • HER2-positive tumors;
  • performance status 0-2.

Who cannot join

  • metastases;
  • previous treatment with chemotherapy, radiation therapy or hormone therapy for a breast tumor;
  • clinically significant cardiovascular disease, or history of thrombotic disorders.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

France28 sites

  • Study site

    Besançon, 25030

  • Study site

    Bordeaux, 33000

  • Study site

    Brest, 29609

  • Study site

    Caen, 14076

  • Study site

    Clermont-Ferrand, 63011

  • Study site

    Dijon, 21079

  • Study site

    La Tronche, 38700

  • Study site

    Lille, 59020

  • Study site

    Lyon, 69373

  • Study site

    Marseille, 13273

  • Study site

    Montpellier, 34298

  • Study site

    Nantes, 44202

  • Study site

    Nice, 06189

  • Study site

    Paris, 75231

  • Study site

    Paris, 75475

  • Study site

    Paris, 75970

  • Study site

    Reims, 51056

  • Study site

    Rennes, 35042

  • Study site

    Rouen, 76038

  • Study site

    Saint-Brieuc, 22015

  • Study site

    Saint-Cloud, 92210

  • Study site

    Saint-Herblain, 44805

  • Study site

    Saint-Priest-en-Jarez, 42271

  • Study site

    Strasbourg, 67065

  • Study site

    Strasbourg, 67098

  • Study site

    Toulouse, 31059

  • Study site

    Vandœuvre-lès-Nancy, 54511

  • Study site

    Villejuif, 94805

Other trials in France

About this study

Official title: An Open Label Study to Assess the Rate of Pathological Complete Response in Patients With Primary Inflammatory HER2-positive Breast Cancer Treated With Avastin + Herceptin Based Chemotherapy

This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Conditions
Breast Cancer
Being tested
Standard chemotherapy, bevacizumab [Avastin], trastuzumab [Herceptin]
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard chemotherapyDrug

    As prescribed

  • bevacizumab [Avastin]Drug

    15mg/kg iv 3 weekly in cycles 1-8

  • trastuzumab [Herceptin]Drug

    8mg/kg iv loading dose followed by 6mg/kg iv 3 weekly in cycles 5-8.

Study groups in NCT00717405
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Standard chemotherapy; Drug: bevacizumab [Avastin]; Drug: trastuzumab [Herceptin]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification

    PCR was assessed at the time of definitive surgery according to Sataloff classification and centrally reviewed by an independent committee under blinded conditions. Pathological response was defined based on the therapeutic response at the primary tumor site and axillary lymph nodes. Primary tumor response criteria were as follows: T-A (Total / near total therapeutic effect), T-B (Subjectively greater than [>] 50 percent [%] therapeutic effect but less than [<] T-A), T-C (<50% therapeutic effect, but effect evident), T-D (No therapeutic effect). Axillary lymph node response: N-A (Evidence of therapeutic effect, no metastases), N-B (No therapeutic effect, no nodal metastases), N-C (Nodal metastasis but evident therapeutic effect), N-D (Nodal metastasis with no therapeutic effect). T-A and N-A or T-A and N-B responses were defined as PCR and all other tumor responses as non-responders. Participants with missing values were considered as non-responders.

    Measured: From baseline through Week 25 (Up to 6 months)

Secondary outcomes (13)

  1. Percentage of Participants With a PCR According to the Chevallier Classification

    PCR was assessed at the time of definitive surgery according to Chevallier classification and centrally reviewed by an independent committee under blinded conditions. The Chevallier classification for grading of therapeutic effect related to the primary tumor site and axillary lymph nodes was defined by microscopic changes as follows - Grade 1: Disappearance of all tumors either in the breast or in the nodes, Grade 2: Persistence of carcinoma in situ in the breast only and no nodal invasion, Grade 3: Presence of invasive carcinoma with stromal alteration, Grade 4: Presence of invasive carcinoma without modification. Grade 1 response was considered as PCR. Participants with missing values were considered as non-responders.

    Measured: From baseline through Week 25 (Up to 6 months)

  2. Percentage of Participants Who Were Responders Based on Inflammatory Signs From Baseline at Cycle 5 and Final Treatment Visit

    Breast tumor was physically evaluated during the study which included assessment for inflammatory signs and for overall clinical response. Participant with response from baseline based on inflammatory signs at Cycle 5 and final treatment visit were presented.

    Measured: Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25)

  3. Percentage of Participants Who Were Responders Based on Overall Clinical Response From Baseline at Cycle 5 and Final Treatment Visit

    Breast tumor was physically evaluated during the study which included assessment for inflammatory signs and for overall clinical response. Participant with response from baseline based on overall clinical response at Cycle 5 and final treatment visit were presented.

    Measured: Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25)

  4. Number of Participants Who Underwent Mastectomy

    Surgery included a mastectomy with axillary node dissection and had to be performed at least 4 weeks after the last infusion of neoadjuvant bevacizumab treatment.

    Measured: Anytime between Week 26 and Week 29

  5. Percentage of Participants With Macroscopically Visible Tumor

    Local pathologists assessed the tumor whether it was macroscopically visible or not and percentage of participants for whom the tumor was macroscopically visible was reported.

    Measured: Anytime between Week 26 and Week 29

  6. Percentage of Participants Who Underwent Lymph Node Resection

    Among the participants who were planned to undergo mastectomy, lymph node resection was also performed by the physician depending up on the participant's breast cancer grades.

    Measured: Anytime between Week 26 and Week 29

  7. Breast Cancer Marker CA15.3 at Baseline, Neoadjuvant Final Visit and Change From Baseline at Neoadjuvant Final Visit

    Measured: Baseline, Neoadjuvant Final Visit (Week 25)

  8. Percentage of Participants Who Were Disease Free at 3 and 5 Years

    A participant was considered disease free if the participant did not experience any of the following events: local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colon carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause.

    Measured: 3, 5 years

  9. Disease Free Survival (DFS) Duration

    DFS was estimated using Kaplan-Meier method.

    Measured: Up to 5 Years

  10. Percentage of Participants Who Were Recurrence Free at 3 and 5 Years

    A participant was considered recurrence free if the participant did not experience local or regional recurrence (wall or axillaries nodes), or occurrence of distant metastases (including soft tissue and distal lymph nodes).

    Measured: 3, 5 years

  11. Recurrence Free Survival (RFS) Duration

    RFS was estimated using Kaplan-Meier method.

    Measured: Up to 5 Years

  12. Percentage of Participants Who Were Alive at 3 and 5 Years

    Measured: 3, 5 years

  13. Overall Survival (OS) Duration

    OS was defined as the time from the first administration of neoadjuvant treatment to death of any cause. OS was estimated using Kaplan-Meier method.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionApr 2010
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00717405
Sponsor's protocol ID
ML21531
Other IDs
2008-000783-16, 2008
Status last verified
Jul 2016
First submitted
16 Jul 2008
Last updated
2 Aug 2016

Publications

  • Pierga JY, Petit T, Delozier T, Ferrero JM, Campone M, Gligorov J, Lerebours F, Roche H, Bachelot T, Charafe-Jauffret E, Pavlyuk M, Kraemer S, Bidard FC, Viens P. Neoadjuvant bevacizumab, trastuzumab, and chemotherapy for primary inflammatory HER2-positive breast cancer (BEVERLY-2): an open-label, single-arm phase 2 study. Lancet Oncol. 2012 Apr;13(4):375-84. doi: 10.1016/S1470-2045(12)70049-9. Epub 2012 Feb 28.

    PubMed 22377126

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Standard chemotherapy, bevacizumab [Avastin] and trastuzumab [Herceptin] in people with Breast Cancer, run by Hoffmann-La Roche at 28 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification (time frame: From baseline through Week 25 (Up to 6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00717405, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2016.

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