Phase IB/II study of oncology combinations in 1L Stage IV TNBC

• Research type

  Research Study

• Full title

  A Phase IB/II, 2-Stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) in Combination with Paclitaxel and Multiple Novel Oncology Therapies and Durvalumab (MEDI4736) + Paclitaxel for First-line Metastatic Triple Negative Breast Cancer (BEGONIA)

• IRAS ID

  248334

• Contact name

  Adesola Obunge

• Contact email

  adesola.obunge@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2018-000764-29

• Duration of Study in the UK

  3 years, 6 months, days

• Research summary

  This study will compare a potential new treatment for patients who have a certain type of breast cancer. The study will check how safe, tolerable and effective the new treatments (durvalumab, or durvalumab + novel therapy), in combination with standard chemotherapy (paclitaxel), are in the first-line treatment of these patients. The new treatments aim to enhance the body’s natural defence to a tumour. It is hoped the new treatments will more effective, but it’s not known at present which is why the study is being performed.

  The study will include approximately 325 subjects, across two parts, at sites with expertise in the treatment of breast cancer. To participate, patients must be >18 years and have triple negative breast cancer (TNBC). A tissue sample (biopsy) is required and must be less than 3 years old.

  Patients in Part 1 of the study will be assigned to one of the five treatment groups:
  1. durvalumab + chemotherapy (D+C)
  2. D+C + oleclumab
  3. D+C + selumetinib
  4. D+C + danvatirsen
  5. D+C + capivasertib

  In Part 2, patients will be assigned to one of two or more treatment groups (Arm 1 above, and additional arms, pending confirmation from Part 1).

  Some of the new treatments will be administered in to a vein, over 1-2 hours. Others are taken orally.

  Eligible patients will visit the hospital once every 4 weeks, with extra treatment visits taking place weekly or more frequently, depending on the treatment group. They may undergo tests such as physical exams, blood and urine. Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI) scans of their tumours will take place every 8-12 weeks.

  When a patient stops study treatment, they will remain in the study for long term follow-up of their disease outcome.

  The study is anticipated to continue until June 2024.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  18/SW/0247

• Date of REC Opinion

  29 Nov 2018

• REC opinion

  Further Information Favourable Opinion