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New treatment option for Breast Cancer
Official title NEODOXy: Targeting Breast Cancer Stem Cells With Doxycycline
ClinicalTrials.gov ID: NCT06452394
What this study is testing
What is Doxycyclin?
Doxycyclin is an investigational medicine, being studied as a potential treatment for breast cancer.
Also referred to as Doxyclin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patients with multiple synchronous ipsilateral tumors are allowed, as long as all lesions are ER+/HER2-. Only one target lesion will be considered...
- Patients are planned for neoadjuvant chemotherapy according to the local standards.
You likely can't join if
- 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).
- Concomitant or recent (within 30 days of registration) treatment with any other experimental drug.
- Concomitant use of drugs contraindicated with doxycycline according to the Swissmedic-approved product information or contraindicated according to...
See the full eligibility criteria
- 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...
- Patients are planned for neoadjuvant chemotherapy according to the local standards.
- Patients accept standard curative surgery after neoadjuvant chemotherapy with 4 cycles of epirubicin and cyclophosphamide (EC) followed by 12 doses of weekly paclitaxel (or nab-paclitaxel).
- Diagnostic tumor tissue is available for the mandatory central pathology examinations; or an additional biopsy is planned in case of lack of remaining material from the diagnostic biopsy, provided that the patient has...
- Patients with a prior malignancy and treated with curative intention are eligible if all treatment of that malignancy was completed at least 2 years before registration in this trial and the patient has no evidence of...
- Male or female patients age ≥ 18 years.
- ECOG performance status 0-1.
- Adequate bone marrow function:
- neutrophil count ≥ 1.5 x 10\^9/L,
- platelet count ≥ 100 x 10\^9/L,
- hemoglobin ≥ 90 g/L.
- Adequate hepatic function:
- total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's disease max. 3.0 x ULN),
- AST and ALT ≤ 2.5 x ULN.
- Adequate renal function: estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2 (according to CKD-EPI formula).
- No known cardiac dysfunction contraindicating the planned neoadjuvant chemotherapy with 4 cycles of EC followed by 12 doses of weekly paclitaxel.
- Women of childbearing potential must use highly effective, are not pregnant or lactating and agree not to become pregnant during trial treatment and until 12 months after the last dose of investigational drug. A...
- Men agree not to donate sperm or to father a child during trial treatment and until 12 months after the last dose of investigational drug.
- Patient is able and willing to swallow trial drug as whole tablet.
- 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).
- Concomitant or recent (within 30 days of registration) treatment with any other experimental drug.
- Concomitant use of drugs contraindicated with doxycycline according to the Swissmedic-approved product information or contraindicated according to the trial protocol.
- Use of dietary supplements, natural therapies, phytotherapy or complementary and integrative medicines (homeopathy, spagyric remedies, etc) without approval of the sponsor.
- Concomitant use of other anti-cancer drugs or radiotherapy.
- Patients having received doxycycline or other antibiotics of the cyclin family within 28 days before registration.
- Known hypersensitivity to cyclin group of substances, including tetracyclines, doxycycline or to any component of the trial drug.
- Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect...
The study team makes the final eligibility decision.
Where it's taking place
- Sankt Gallen, Canton of St. Gallen, Switzerland
- Genolier, Canton of Vaud, Switzerland
- Winterthur, Canton of Zurich, Switzerland
- Chur, Kanton Graubünden, Switzerland
- Aarau, Switzerland
- Lausanne, Switzerland
- Sankt Gallen, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sankt Gallen, Canton of St. Gallen, Switzerland; Genolier, Canton of Vaud, Switzerland; Winterthur, Canton of Zurich, Switzerland; Chur, Kanton Graubünden, Switzerland; Aarau, Switzerland; Lausanne, Switzerland and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.