Clinical Trial: Study of Panobinostat Monotherapy in Women With v-ERB-B2 Avian Erythroblastic Leukemia Viral Oncogene Homolog 2 (HER2) Positive Locally Recurrent or Metastatic Breast Cancer
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Randomized Phase II, Open-label Multicenter Trial of Panobinostat Monotherapy in Women With HER2 Positive Locally Recurrent or Metastatic Breast Cancer
Brief Summary: The purpose of the study is to assess the benefit of panobinostat monotherapy given either orally or i.v. to women with HER2-positive locally recurrent or metastatic breast cancer
Detailed Summary:
Sponsor: Translational Research in Oncology
Current Primary Outcome: Overall Response (OR) Rate (as Determined by the Investigator): the Number of Patients Assigned to a Treatment Arm With a Confirmed Best Response of Complete Response(CR) or Partial Response (PR). [ Time Frame: At screening, every 2 cycles (i.e. 6 weeks) during the first 6 cycles, every 3 cycles (i.e. 9 weeks) during the subsequent cycles and at the End of Treatment (EOT) visit. After the EOT, the tumor assessments should be performed every 9 weeks. ]
The assessment of OR is based on the response of target lesion, of non-target lesion and on presence of new lesions (RECIST Criteria (V1.0)-assessed by CT scan spiral and bone scan)
- CR:Disappearance of all target lesions
- PR:>=30% increase in the sum of the longest diameter (SLD),taking as reference the nadir SLD
- Progressive Disease (PD):>=20% increase in the SLD, taking as reference the nadir SLD, or the appearance of one or more new lesions
- Stable Disease(SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the nadir SLD
Original Primary Outcome: Objective response rate (as determined by the investigator): the percentage of patients assigned to a treatment arm with a confirmed best response of CR or PR. [ Time Frame: Once 21 evaluable patients have been treated and then once 66 evaluable patients have been treated. ]
Current Secondary Outcome: Corrected QT Interval Fridericia's Formula (QTcF) [ Time Frame: Panobinostat intra-venous (i.v.): All cycles pre-dose measurements. For cycles 1 and 2, post-dose measurements as well. / Panobinostat oral: Pre-dose and post-dose measurements for all cycles. Note: each cycle = 3 weeks ]
Original Secondary Outcome:
Information By: Translational Research in Oncology
Dates:
Date Received: October 21, 2008
Date Started: February 2009
Date Completion:
Last Updated: October 27, 2015
Last Verified: October 2015
