Phase 2/3 study of nab-paclitaxel in metastatic breast cancer

• Research type

  Research Study

• Full title

  A PHASE 2/3, MULTI-CENTER, OPEN-LABEL, RANDOMIZED STUDY OF WEEKLY nab®-PACLITAXEL IN COMBINATION WITH GEMCITABINE OR CARBOPLATIN, COMPARED TO GEMCITABINE/CARBOPLATIN, AS FIRST LINE TREATMENT IN SUBJECTS WITH ER, PgR, AND HER2 NEGATIVE (TRIPLE NEGATIVE) METASTATIC BREAST CANCER

• IRAS ID

  130143

• Contact name

  Rob Coleman

• Contact email

  r.e.coleman@sheffield.ac.uk

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2013-000113-20

• Clinicaltrials.gov Identifier

  NCT01881230

• Research summary

  Triple-negative breast cancer (TNBC) represents approximately 15% of all breast cancers. Compared to other types of breast cancer patients diagnosed with TNBC are usually younger, with a higher likelihood of recurrence within the first 3 years and a lower chance of survival. TNBC patients do not benefit from treatment with endocrine therapy or trastuzumab, so current available treatment options are limited. Therefore, there is an unmet need to provide this population with further treatment options.

  Currently, nab-paclitaxel is approved as a second line treatment for advanced breast and lung cancer in different parts of the world. The purpose of the Phase 2 portion of the study is to evaluate the effect of the two nab-paclitaxel experimental arms and identify which nab-paclitaxel combination will be used in the Phase 3 portion of the study. Subjects will know which study medication they are receiving. The purpose of the Phase 3 portion is to compare the progression free survival (PFS) of nab-Paclitaxel plus either gemcitabine or carboplatin to gemcitabine/carboplatin.

  In Phase 2, participants will be assigned to one of three treatment groups:
  • nab-Paclitaxel/Gemcitabine
  • nab-Paclitaxel/Carboplat in
  • Gemcitabine / Carboplatin
  In phase 3, participants will be assigned to one of two treatment groups:
  • nab-Paclitaxel / Carboplatin or nab-Paclitaxel / Gemcitabine (depending on the selected Phase 2 nab-paclitaxel arm)
  • Carboplatin / Gemcitabine

  The length of subjects’ participation is approximately 1 year. Study procedures include physical exams, vital signs, blood tests, ECGs, shipment of previously collected tumour samples, CT, MRI scans, bone scans and questionnaires.

  This study is sponsored by Abraxis BioScience, LLC, a wholly-owned subsidiary of
  Celgene Corporation. Approximately 790 subjects from 160 sites worldwide will participate. Up to 240 subjects will take part in Phase 2 and approximately 550 in Phase 3. In the UK, approximately 18 subjects will be recruited into each phase of the study.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  13/NW/0637

• Date of REC Opinion

  28 Oct 2013

• REC opinion

  Further Information Favourable Opinion