Phase III, prospective, multi-center, randomized, open label, parallel group, study in
patients with HER2-negative breast cancer with residual disease after neoadjuvant
chemotherapy with 1:1 allocation to:
Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles);
Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based
chemotherapy for eight cycles or observation.
Treatment in either arm will be given for eight cycles.
In patients with HR-positive breast cancer, endocrine-based therapy will be administered
according to local guidelines. The start of endocrine therapy will be at the discretion of
the investigator; however, it will be encouraged to start after surgery/radiotherapy in
patients without additional cytotoxic agents.
Neoadjuvant chemotherapy (NACT) allows monitoring of tumor response to treatment and a
pathological complete response (pCR) is associated with superior survival. This association
is strongest in the most aggressive subtype, i.e. in patients with triple-negative breast
cancer (TNBC). Patients with TNBC not achieving a pCR have a 5-year event free survival rate
of about 50%. , , The association between pCR and prognosis is less pronounced in
HR-positive/HER2-negative patients. However, the CPS+EG scoring system for prognosis after
neoadjuvant chemotherapy, taking into account clinical stage, post treatment pathological
stage, estrogen receptor status and grade, leads to an improved estimate of prognosis
allowing to select patients at high risk of relapse for post-neoadjuvant therapy. Patients
with TNBC not achieving a pCR as well as those with HR-positive/HER2-negative tumors and a
CPS+EG score of 3 or 2/ypN+ are at high risk of relapse, warranting additional experimental
therapies after NACT.
There is proof of concept, that post-neoadjuvant therapy can significantly improve survival.
First data was provided by the CREATE X trial, randomizing patients with residual tumor after
neoadjuvant chemotherapy to either capecitabine or observation. CREATE X included
HER2-negative patients and demonstrated a significant improvement in disease-free survival
(DFS) and overall survival (OS) in the overall population, which was confined to the TNBC
Recently, the randomized post-neoadjuvant phase III KATHERINE study demonstrated an improved
invasive disease-free survival in HER2-positive patients without pCR after trastuzumab +/-
pertuzumab treated postoperatively with T-DM1, an antibody-drug-conjugate compared to
HER2-negative Breast Cancer, Triple Negative Breast Cancer
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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