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

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• Breast Neoplasms 12,544

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 52 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Study arms

• Experimental
  1

  Drug: Standard chemotherapy · Drug: bevacizumab [Avastin] · Drug: trastuzumab [Herceptin]

Interventions

• DrugStandard chemotherapy

  As prescribed

• Drugbevacizumab [Avastin]

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

• Drugtrastuzumab [Herceptin]

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

Primary outcomes

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.

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

Secondary outcomes

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.

   Time frame: 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.

   Time frame: 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.

   Time frame: 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.

   Time frame: 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.

   Time frame: 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.

   Time frame: 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

   Time frame: 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.

   Time frame: 3, 5 years

9. Disease Free Survival (DFS) Duration

   DFS was estimated using Kaplan-Meier method.

   Time frame: 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).

    Time frame: 3, 5 years

11. Recurrence Free Survival (RFS) Duration

    RFS was estimated using Kaplan-Meier method.

    Time frame: Up to 5 Years

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

    Time frame: 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.

    Time frame: Up to 5 years

Baseline characteristics

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 ↗