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Ensayo clínico de Sacituzumab Govitecan en pacientes con cáncer primario de mama HER2 negativo con alto riesgo de recaída

THE SASCIA TRIAL IS DESIGNED TO EVALUATE WHETHER ADMINISTRATION OF SACITUZUMAB GOVITECAN HAS ADDED BENEFIT COMPARED TO A TREATMENT OF YOUR PHYSICIAN'S CHOICE (NO TREATMENT/OBSERVATION, TREATMENT WITH CAPECITABINE OR A PLATINUM-BASED PREPARATION). IN ADDITION, IF INDICATED IN THE PATIENT'S CASE, HE WILL RECEIVE RADIATION THERAPY (BEFORE STARTING THE TRIAL) AND, IF THE CANCER IS HORMONE-DEPENDENT, HE WILL ALSO RECEIVE ANTI-HORMONE THERAPY. THESE THERAPIES ARE STANDARD TREATMENTS AND ARE NOT PART OF THE STUDY. THE STUDY MEDICATION, SACITUZUMAB GOVITECAN, IS A DRUG THAT BELONGS TO THE GROUP OF SO-CALLED "ARMED" ANTIBODIES. ANTIBODIES ARE A SPECIAL GROUP OF PROTEINS THAT HAVE THE ABILITY TO RECOGNIZE AND BIND TO CERTAIN STRUCTURES ON THE SURFACE OF CELLS. SACITUZUMAB GOVITECAN IS COMPOSED OF AN ANTIBODY, CALLED SACITUZUMAB, ASSOCIATED WITH THE CHEMOTHERAPY AGENT IRINOTECAN. IRINOTECAN IS A LONG-KNOWN DRUG USED TO TREAT VARIOUS TUMORS, INCLUDING BREAST CANCER. THE ANTIBODY SACITUZUMAB BINDS SPECIFICALLY TO THE SURFACE OF CANCER CELLS BY RECOGNIZING THE TROP-2 PROTEIN, A SPECIFIC FEATURE OF CANCER CELLS. ONCE SACITUZUMAB HAS BOUND TO TROP-2, THE IRINOTECAN CAN ENTER THE CANCER CELL. THE DRUG RELEASED IN THIS WAY IS ABLE TO CAUSE TUMOR CELL DEATH (FIGURE 1). THUS, IRINOTECAN ACTS SPECIFICALLY ON CANCER CELLS. BECAUSE OF THIS MECHANISM OF ACTION, NORMAL CELLS IN THE BODY ARE LIKELY TO BE SLIGHTLY AFFECTED BY IRINOTECAN. THE AIM OF THE SASCIA STUDY IS TO FIND OUT WHETHER THIS STRATEGY INCREASES THE EFFECTIVENESS OF THERAPY AND REDUCES SIDE EFFECTS COMPARED WITH STANDARD THERAPY.

Status
In recruitment
headquarters
Multisede

Technical Summary

  • PHASE III POST-NEOADJUVANT STUDY EVALUATING SACITUZUMAB GOVITECAN, A CONJUGATED ANTIBODY, IN PATIENTS WITH HER2-NEGATIVE PRIMARY BREAST CANCER AT HIGH RISK OF RELAPSE AFTER STANDARD NEOADJUVANT TREATMENT - SASCIA. IMMUNOTHERAPY
  • Code EudraCT: 2019-004100-35
  • Protocol number: GBG 102
  • Promoter: GBG Forschungs GmbH
  • Link to Clinical Trials

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

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