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SAKK 23/18 - VISION I

Breast cancer: is surgery still necessary if tumor tissue can no longer be detected following chemotherapy?

With some patients who receive neoadjuvant chemotherapy for breast cancer, the subsequent magnetic resonance imaging (MRI) scan shows no further evidence of tumor tissue. Do these patients still need surgery to remove the former tumor tissue?

Certain patients with breast cancer are given neoadjuvant chemotherapy (NCT) before the tumor is surgically removed. In some cases, the tumor can no longer be detected by imaging methods following the NCT. Nevertheless, the original tumor tissue is removed from these patients to ensure complete tumor resection. It is thought that this surgery may actually be unnecessary for some of these patients, since the tumor has been completely destroyed by the NCT. This can be demonstrated by a tumor biopsy after the NCT. If the biopsy reveals that there is no longer any tumor tissue in a patient after NCT, surgery could be avoided.

Vacuum-assisted biopsy before tumor surgery

The SAKK 23/18 trial will examine this hypothesis. In cases where an MRI scan shows no or almost no tumor tissue in breast cancer patients following NCT, a vacuum-assisted biopsy (VAB) will be carried out before tumor surgery. An analysis of the tissue samples obtained in this way should show whether any tumor tissue is still present in these patients.

Process for participation in the trial

  • The VAB will be carried out shortly before tumor surgery, which takes place within six weeks of the last NCT.
  • The patient will then undergo surgery, as in the standard therapy.
    In contrast to patients who are not recruited to the trial, the participants will have both the VAB and tumor surgery (the other patients will only have surgery).


420 patients are expected to be included in the trial.

Clinics

  • Bethesda Spital
  • Brust-Zentrum AG - Klinik Hirslanden
  • Clinique de Genolier
  • Ente Ospedaliero Cantonale (EOC)
  • Hirslanden Klinik St. Anna
  • Hirslanden Salem-Spital
  • INACTIVE KSB Kantonsspital Baden AG
  • Kantonsspital Graubünden
  • Kantonsspital Winterthur
  • Luzerner Kantonsspital AG
  • Spital Thurgau AG - Network
  • St. Claraspital AG
  • TBZO Tumor- und BrustZentrum Ostschweiz - St. Gallen
  • TZA Tumor Zentrum Aargau - Hirslanden Medical Center
  • Universitätsspital Basel
  • USZ Universitätsspital Zürich

Further Studies: Breast cancer

SAKK 66/22

Triple-negative (hormone-independent) breast cancer, TNBC

SAKK 23/16 TAXIS

Surgical lymph node removal with the option of “extensive operation” or “radiotherapy” in breast cancer patients with existing axillary lymph node involvement

CAMBRIA-2

Researchers are looking for a better way to treat ER+/HER2- early-stage breast cancer

SAKK 21/23 NEODOXy

Does doxycycline improve breast cancer treatment?

IBCSG 50-14 OLYMPIA

A randomised, double-blind, parallel group, placebo-controlled multi-centre Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.

IBCSG 52-15 PALLAS

PALLAS: PALbociclib CoLlaborative Adjuvant Study: A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

IBCSG 67-22 PREcoopERA

A Window-of-Opportunity trial of giredestrant +/- triptorelin vs. anastrozole + triptorelin in premenopausal patients with ER-positive/HER2-negative early breast cancer.

IBCSG 48-14 POSITIVE

A study evaluating the pregnancy outcomes and safety of interrupting endocrine therapy for young women with endocrine responsive breast cancer who desire pregnancy (POSITIVE).