NEODOXy: Targeting Breast Cancer Stem Cells With Doxycycline
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSwiss Cancer Institute
About this trial
Despite modern surgical and medical treatments, breast cancer can re-occur and lead 20% of patients to death. During the last 20 years, pre-clinical studies have shown that treatment failures may be due to the presence of a sub-type of cancer cells, the cancer stem cells, which are resistant to chemotherapy and radiotherapy. By chance, doxycycline, an old, inexpensive and safe molecule seems to target effectively these cancer stem cells. This study proposes to check for the clinical efficacy of doxycycline to target the cancer stem cells and improve the response to neoadjuvant chemotherapy in ER+/HER2- breast cancers.
Eligibility criteria
Qualifiers
Written informed consent according to Swiss law and current ICH GCP E6 regulations before registration and prior to any trial specific procedures.
Histologically confirmed ER+/HER2- primary invasive breast cancer, according to ASCO/CAP Guideline1,2, defined as ER expression rate ≥ 1%.
Patients are candidate for curative surgery and with a tumor size of at least 2 cm and nodal classification cN0-3 according to the 8th edition, January 2017 of the anatomic TNM classification3.
Patients with multiple synchronous ipsilateral tumors are allowed, as long as all lesions are ER+/HER2-. Only one target lesion will be considered for ALDH1 primary endpoint, and the target lesion has to be the largest lesion.
Disqualifiers
Patients with 2 synchronous breast cancers or more of different subtypes (other than ER+/HER2-).
Metastatic patients.
Patients having received or planned to undergo neoadjuvant endocrine therapy or other investigational therapies before surgery.
History of intracranial hypertension (IH).
Trial design
Treatments tested in this trial
- Doxycyclin
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov