ABCSG 28/Posytive – Details

Primary Operation in Synchronous meTastasized InVasivE breast cancer, a multicenter, prospective, randomized study to evaluate the use of local therapy

Start:
12/2010

Contact ABCSG-Trial office

E-mail: info@abcsg.at
Phone: +43 1 408 92 30
Fax: +43 1 409 09 90

Design

Design-ABCSG-28
Click to enlarge

Primary objectives:

  • To evaluate the median survival of patients with synchronous metastasized breast cancer and the primary tumor in place comparing arm A with local therapy to the primary tumor versus arm B without local therapy

Secondary objectives:

  • To evaluate time to distant and local progression as well as in pre-selected centers circulating tumor cells and growth factors in the peripheral blood within the two groups

General inclusion criteria:

  1. Written informed consent must be obtained and documented prior to beginning any protocol specific procedures and according to local regulatory requirements
  2. Patients age ≥ 18 years
  3. Eastern Cooperative Oncology Group Performance Status is 0 -2
  4. Able to comply with the protocol requirements during the treatment and follow-up period

Disease specific inclusion criteria:

  1. Untreated synchronous metastasized invasive carcinoma of the breast with the primary tumor in situ (bilateral synchronous metastasized breast cancer patients are eligible)
  2. The primary tumor must be identified and may be any size, however, primary resection with resection free margins must be possible
  3. Invasive adenocarcinoma of the breast on histological examination
  4. The metastatic site must be identified by radiological assessment (Computer Tomography of the chest and the abdomen OR ultrasound and chest x ray for visceral metastases; bone scan AND/OR computer tomography AND/OR magnetic resonance for bone metastases). A biopsy is not necessary.

Exclusion criteria:

  1. Patients in whom a R0 resection (microscopic free margins) is clinically questionable
  2. Inflammatory cancer
  3. Patients with brain metastases
  4. Patients who are not eligible for general anesthesia and operations
  5. Patients without metastatic breast cancer (patients with a tumor marker value (CEA, CA15-3) above normal levels without the radiological proven evidence of metastases are not eligible for the study)
  6. Patients with a second untreated malignancy
  7. Any previous malignancy treated with curative intent and the patient has not been disease-free for 5 years – exceptions are:
    • carcinoma in situ of the cervix
    • squamous carcinoma of the skin
    • basal cell carcinoma of the skin
  8. Patients with any recurrent cancer disease
  9. Pregnant or lactating women
  10. Patients are not allowed to be part of another local therapy trial