IBCSG 27-02/BIG 1-02

• Research type

  Research Study

• Full title

  A Randomised clinical trial of adjuvant chemotherapy for radically resected loco-regional relapsed of breast cancer

• IRAS ID

  19150

• Sponsor organisation

  IBCSG

• Eudract number

  2005-001484-64

• Research summary

  The study is designed to find out whether adjuvant chemotherapy following risection of an operable local or regional recurrence of breast cancer improves outcome compared with observation. Adjvuant chemotherapy prevents recurrences and death after primary surgical treatment of breast cancer; it is hypothesized that chemotherapy will delay further tumour recurrences after a first local or regional relapse. The design of the trial is indicated in the diagram included (Appendix 1) The control arm (Arm A) has no adjuvant chemotherapy as there is as yet no randomised trial to show benefit at prisent. patients who have undergone complete surgical removal of an isolated local and / or regional recurrence of invasive breast cancer after mastectomy or breast-conserving surgery are able to be entered into the trial within 6 weeks of their surgery. patients willbe randomly assigned to recieve chemotherapy or not patients will be randomised within 6 weeks of risection and treated within 4 weeks after randomisation. They will be randomly assigned to either receive a course of chemotherapy or not. The choice of chemotherapy drugs and schedule will be made by the treating doctors and may depend on factors such as the patient's previous treatments. All patientstaking part in the trial will have baseline blood tests and scans/xrays. Most of these would in fact be done as standard practice and will include a chest x-ray or CT scan of chest: an isotope bone scan; and an Ultrasound or CT scan of the liver. All patients will also require mammograms to monitor any remaining breast tissue. patients on both areas will receive alls standard therapies in this situation including surgery, radiotherapy and hormone therapy if indicated. If their cancer cells overexpriss the HER2 protein, they may also receive herceptin at the discretion of and on discussion with their treating doctor.

• REC name

  HSC REC A

• REC reference

  09/NIR01/33

• Date of REC Opinion

  28 Jul 2009

• REC opinion

  Further Information Favourable Opinion