Actively Recruiting
NEODOXy: Targeting Breast Cancer Stem Cells With Doxycycline
Led by Swiss Cancer Institute · Updated on 2025-12-30
50
Participants Needed
8
Research Sites
180 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NEODOXy: Targeting Breast Cancer Stem Cells With Doxycycline
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, defined as ER expression rate 1%.
- Candidate for curative surgery with tumor size of at least 2 cm and nodal classification cN0-3.
- Multiple synchronous ipsilateral tumors allowed if all are ER+/HER2-; only the largest lesion considered for ALDH1 endpoint.
- Planned neoadjuvant chemotherapy according to local standards.
- Planned standard curative surgery after chemotherapy with 4 cycles of epirubicin and cyclophosphamide followed by 12 weekly paclitaxel or nab-paclitaxel doses.
- Diagnostic tumor tissue available for central pathology or additional biopsy planned with consent.
- Prior malignancy treated with curative intent completed at least 2 years before registration (exceptions for certain cancers).
- Male or female patients age 18 years.
- ECOG performance status 0-1.
- Adequate bone marrow function with neutrophils 1.5 x10^9/L, platelets 100 x10^9/L, hemoglobin 90 g/L.
- Adequate hepatic function with total bilirubin 1.5 x ULN (up to 3.0 x ULN for Gilbert's disease), AST and ALT 2.5 x ULN.
- Adequate renal function with eGFR 50 mL/min/1.73 m2.
- No known cardiac dysfunction contraindicating planned chemotherapy.
- Women of childbearing potential must not be pregnant or lactating, use highly effective contraception, and have a negative pregnancy test before inclusion.
- Men must agree not to donate sperm or father a child during treatment and for 12 months after last dose.
- Able and willing to swallow trial drug as whole tablet.
You will not qualify if you...
- Patients with 2 or more synchronous breast cancers of different subtypes (other than ER+/HER2-).
- Metastatic patients.
- Previous or planned neoadjuvant endocrine therapy or other investigational therapies before surgery.
- History of intracranial hypertension.
- Treatment with any other experimental drug within 30 days before registration.
- Use of drugs contraindicated with doxycycline according to Swissmedic or trial protocol.
- Use of dietary supplements, natural therapies, phytotherapy, or complementary medicines without sponsor approval.
- Use of other anti-cancer drugs or radiotherapy concurrently.
- Receipt of doxycycline or cyclin antibiotics within 28 days before registration.
- Known hypersensitivity to cyclin substances including tetracyclines or doxycycline.
- Any serious medical, psychiatric, psychological, familial, or geographical condition that may interfere with staging, treatment, follow-up, compliance, or increase risk from treatment complications.
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Kantonsspital St.Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
Actively Recruiting
2
Clinique de Genolier
Genolier, Canton of Vaud, Switzerland, 1272
Actively Recruiting
3
Kantonsspital Winterthur
Winterthur, Canton of Zurich, Switzerland, 8401
Actively Recruiting
4
Kantonsspital Graubünden
Chur, Kanton Graubünden, Switzerland, 7000
Actively Recruiting
5
Tumor Zentrum Aarau
Aarau, Switzerland, 5000
Actively Recruiting
6
Réseau du sein Lausanne
Lausanne, Switzerland, 1004
Actively Recruiting
7
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland, CH-1011
Actively Recruiting
8
Tumor- und Brustzentrum Ostschweiz
Sankt Gallen, Switzerland, 9016
Actively Recruiting
Research Team
D
Daniela Zoelly, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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