Breast CancerPhase 2NCT06452394
NEODOXy: Targeting Breast Cancer Stem Cells With Doxycycline
A Phase 2 study testing Doxycyclin in people with Breast Cancer, run by Swiss Cancer Institute at 8 sites in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Doxycyclin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 8 sitesSwitzerland
- Study dates
- 16 Jul 2025to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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).
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- 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 consented to the optional TR-project.
- 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 disease at registration. Less than 2 years is acceptable for adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer.
- 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 negative pregnancy test before inclusion into the trial is required for all women of childbearing potential.
- 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.
Who cannot join
- 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.
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- 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 patient compliance or place the patient at high risk from treatment-related complications.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Switzerland8 sites, 8 recruiting
- Recruiting
Tumor Zentrum Aarau
Aarau, 5000
Andreas Jakob, MD, +41 62 836 78 30, andreas.jakob@tumor-zentrum.ch
Andreas Jakob, MD
- Recruiting
Kantonsspital Graubünden
Chur, Kanton Graubünden, 7000
Sophie Reinhart, M.D., +41 81 256 66 46, sophie.reinhart@ksgr.ch
- Recruiting
Clinique de Genolier
Genolier, Canton of Vaud, 1272
Magdalena Kohlik, M.D., +41 22 362 60 00, mkohlik@genolier.net
- Recruiting
Réseau du sein Lausanne
Lausanne, 1004
Loïc Lelièvre, MD, +41 79 249 49 73, .lelievre@lasource.ch
Loïc Lelièvre, MD
- Recruiting
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, CH-1011
Khalil Zaman, MD, +41 21 314 01 55, khalil.zaman@chuv.ch
Khalil Zaman, MD
- Recruiting
Kantonsspital St.Gallen
Sankt Gallen, Canton of St. Gallen, 9007
Jens Huober, M.D., +41 71 494 18 88, jens.huober@kssg.ch
- Recruiting
Tumor- und Brustzentrum Ostschweiz
Sankt Gallen, 9016
Patrik Weder, MD, +41 71 552 33 33, patrik.weder@bz-ost.ch
Patrik Weder
- Recruiting
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401
Andreas Müller, MD, +41 52 266 36 44, Andreas.mueller@ksw.ch
Andreas Müller, MD
About this study
Official title: NEODOXy: Targeting Cancer Stem Cells With NEOadjuvant DOXYcycline in Patients With Early Estrogen Receptor Positive / Human Epidermal Growth Factor Receptor 2- Negative Breast Cancer. A Prospective, Multicenter, Single Arm, Open Label Phase II 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.
Read the detailed description
Patients with early stage ER+/HER2- breast cancer (BC) have a low pathologic complete response (pCR) rate of less than 15%. Over the past 20 years, studies have identified a subset of cancer cells with tumorigenic and stem-like properties, known as cancer stem cells (CSCs), that are involved in tumour initiation, metastasis, relapse and resistance to treatment. Cancer cells with stem-like properties are known to possess cellular plasticity that not only enables self-renewal capacity, but also exhibits high tumourigenic potential and resistance to oncological therapies such as chemotherapy and/or radiotherapy.
CSCs can arise from normal adult breast stem cells through mutations or directly from differentiated tumor cells. Tumour hypoxia has been shown to be one of the major factors promoting and maintaining the stemness phenotype. The metabolism of CSCs in hypoxia relies on a delicate balance between reduced energy requirements through reduced proliferation and an altered balance between mitochondrial oxidative phosphorylation ("OXPHOS") and cytosolic glycolysis, while maintaining mitochondrial redox homeostasis to control reactive oxygen species (ROS) levels. Any slight imbalance in mitochondrial redox homeostasis in CSCs, leading to transient effects on ROS, may promote their differentiation towards their non-stem tumour cell counterparts. Consequently, specific drugs targeting mitochondrial metabolism, leading to increased ROS levels, may destabilise CSCs.
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. The change in the stemness marker, ALDH1, assessed before and after treatment and the effect of doxycycline on the pathological response will be studied.
The translational work will be to better define these stem cells and to grow organoid cultures to study the effects of the different drugs in vitro. This study also aims to address a number of translational research questions using a tumor sample obtained from an additional core biopsy prior to treatment initiation and using a fresh tumor sample from the surgical specimen in the case of residual tumor after neoadjuvant treatment:
- Quantify and characterise the effects of doxycycline on tumors
- Identify factors that facilitate or prevent the effects of doxycycline
- Estimate the effect of doxycycline compared to other CSC-targeting drugs
- Conditions
- Breast Cancer
- Being tested
- Doxycyclin
- Keywords
- early ER+/HER2- breast cancer, NEODOXy, Doxycycline, Human Epidermal Growth Factor Receptor 2 negative, Estrogen Receptor, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclinDrug
Also called Doxyclin
Belongs to the class of tetracyclines. It has bacteriostatic activity against a broad range of gram-positive and gram-negative bacteria. Its mechanism of action lies in the binding to the 30S ribosomal subunit
| Study group | Role | What they receive |
|---|---|---|
| NEOadjuvant DOXYcycline | Experimental | neoadjuvant chemotherapy (4 cycles epirubicin 90 mg/m2 + cyclophosphamide 600 mg/m2 q3W followed by 4 cycles weekly paclitaxel (D1, D8, D15) 80 mg/m2)
+ doxycycline (200 mg/day from D5 to D18 of each cycle) Receives: Drug: Doxycyclin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the proportion of patients with ALDH1 positive tumors before and after neoadjuvant chemotherapy plus doxycycline.
Difference in the proportion of patients with Aldehyde Dehydrogenase 1 (ALDH1) positive tumors before and after neoadjuvant chemotherapy plus doxycycline, assessed as follows: Tumor cells expressing ALDH1 will be revealed by immunostaining using an anti-ALDH1 antibody on the pathology slides. In case of residual disease, an ALDH1 positive tumor is defined as having at least 5% of its tumor cells expressing ALDH1. In case of pCR, determined by H\&E staining, ALDH1 will be considered negative.
Measured: From the date of registration to 30 days after last trial treatment
Pathologic complete response rate after surgery, defined as no invasive residual disease in the breast and in the axillary lymph nodes.
Pathologic complete response (pCR) rate after surgery in the breast and in the axillary lymph nodes (if biopsy-proven lymph node involvement prior to neoadjuvant treatment), defined as proportion of patients with no residual invasive cancer for each anatomic location (i.e no viable cancer cell on microscopic examination after Hematoxylin and Eosin (H\&E) staining): ypT0-ypTis ypN0.
Measured: From the date of registration to 30 days after last trial treatment
Secondary outcomes (7)
Percentage of ALDH1 positive tumor cells
Difference in the percentage of ALDH1 positive tumor cells before and after neoadjuvant chemotherapy plus doxycycline
Measured: From the date of registration to 30 days after last trial treatment
Difference in the percentage of ALDH1 positive tumor cells
Category of the difference in the percentage of ALDH1 positive tumor cells before and after neoadjuvant chemotherapy plus doxycycline
Measured: From the date of registration to 30 days after last trial treatment
Pathological residual disease
Pathological residual disease using the validated residual cancer burden score (RCB score)
Measured: From the date of registration to 30 days after last trial treatment
Radiological tumor shrinkage
Radiological tumor shrinkage at mid-term and at completion of neoadjuvant treatment
Measured: From the date of registration to 30 days after last trial treatment
Breast conservation rate
Breast conservation rate at surgery and the rate of conversion from mastectomy to breast conserving surgery
Measured: From the date of registration to 30 days after last trial treatment
Doxycycline adherence rate
Doxycycline adherence rate
Measured: From the date of registration to 30 days after last trial treatment
Patient-reported treatment burden
Patient-reported treatment burden and satisfaction with treatment
Measured: From the date of registration to 30 days after last trial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start16 Jul 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, single arm, open label
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loïc Lelièvre, M.D., Study chair, Centre hospitalier universitaire vaudois (CHUV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452394
- Sponsor's protocol ID
- SAKK 21/23
- Status last verified
- Dec 2025
- First submitted
- 5 Jun 2024
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The translational work will be to better define these stem cells and to grow organoid cultures to study the effects of the different drugs in vitro and will be carried out as part of this trial. Only data from patients who agreed to an additional biopsy of tumour tissue will be used for translational research.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEODOXy: Targeting Cancer Stem Cells With NEOadjuvant DOXYcycline in Patients With Early Estrogen Receptor Positive / Human Epidermal Growth Factor Receptor 2- Negative Breast Cancer. A Prospective, Multicenter, Single Arm, Open Label Phase II Trial
- ClinicalTrials.gov ID
- NCT06452394
- Acronym / sponsor ID
- SAKK 21/23
- Conditions
- Breast Cancer
- Keywords
- early ER+/HER2- breast cancer, NEODOXy, Doxycycline, Human Epidermal Growth Factor Receptor 2 negative, Estrogen Receptor, Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with early stage ER+/HER2- breast cancer (BC) have a low pathologic complete response (pCR) rate of less than 15%. Over the past 20 years, studies have identified a subset of cancer cells with tumorigenic and stem-like properties, known as cancer stem cells (CSCs), that are involved in tumour initiation, metastasis, relapse and resistance to treatment. Cancer cells with stem-like properties are known to possess cellular plasticity that not only enables self-renewal capacity, but also exhibits high tumourigenic potential and resistance to oncological therapies such as chemotherapy and/or radiotherapy.
CSCs can arise from normal adult breast stem cells through mutations or directly from differentiated tumor cells. Tumour hypoxia has been shown to be one of the major factors promoting and maintaining the stemness phenotype. The metabolism of CSCs in hypoxia relies on a delicate balance between reduced energy requirements through reduced proliferation and an altered balance between mitochondrial oxidative phosphorylation ("OXPHOS") and cytosolic glycolysis, while maintaining mitochondrial redox homeostasis to control reactive oxygen species (ROS) levels. Any slight imbalance in mitochondrial redox homeostasis in CSCs, leading to transient effects on ROS, may promote their differentiation towards their non-stem tumour cell counterparts. Consequently, specific drugs targeting mitochondrial metabolism, leading to increased ROS levels, may destabilise CSCs.
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. The change in the stemness marker, ALDH1, assessed before and after treatment and the effect of doxycycline on the pathological response will be studied.
The translational work will be to better define these stem cells and to grow organoid cultures to study the effects of the different drugs in vitro. This study also aims to address a number of translational research questions using a tumor sample obtained from an additional core biopsy prior to treatment initiation and using a fresh tumor sample from the surgical specimen in the case of residual tumor after neoadjuvant treatment:
- Quantify and characterise the effects of doxycycline on tumors
- Identify factors that facilitate or prevent the effects of doxycycline
- Estimate the effect of doxycycline compared to other CSC-targeting drugs
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, single arm, open label
| Arm | Type | Receives |
|---|---|---|
| NEOadjuvant DOXYcycline | Experimental | Drug: Doxycyclinneoadjuvant chemotherapy (4 cycles epirubicin 90 mg/m2 + cyclophosphamide 600 mg/m2 q3W followed by 4 cycles weekly paclitaxel (D1, D8, D15) 80 mg/m2) + doxycycline (200 mg/day from D5 to D18 of each cycle) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
- Patients are planned for neoadjuvant chemotherapy according to the local standards.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclinAlso: DoxyclinBelongs to the class of tetracyclines. It has bacteriostatic activity against a broad range of gram-positive and gram-negative bacteria. Its mechanism of action lies in the binding to the 30S ribosomal subunit | Drug | NEOadjuvant DOXYcycline |
Primary outcome
Difference in the proportion of patients with ALDH1 positive tumors before and after neoadjuvant chemotherapy plus doxycycline.
Time frame: From the date of registration to 30 days after last trial treatment
Difference in the proportion of patients with Aldehyde Dehydrogenase 1 (ALDH1) positive tumors before and after neoadjuvant chemotherapy plus doxycycline, assessed as follows: Tumor cells expressing ALDH1 will be revealed by immunostaining using an anti-ALDH1 antibody on the pathology slides. In case of residual disease, an ALDH1 positive tumor is defined as having at least 5% of its tumor cells expressing ALDH1. In case of pCR, determined by H\&E staining, ALDH1 will be considered negative.
Pathologic complete response rate after surgery, defined as no invasive residual disease in the breast and in the axillary lymph nodes.
Time frame: From the date of registration to 30 days after last trial treatment
Pathologic complete response (pCR) rate after surgery in the breast and in the axillary lymph nodes (if biopsy-proven lymph node involvement prior to neoadjuvant treatment), defined as proportion of patients with no residual invasive cancer for each anatomic location (i.e no viable cancer cell on microscopic examination after Hematoxylin and Eosin (H\&E) staining): ypT0-ypTis ypN0.
7 secondary outcomes
Percentage of ALDH1 positive tumor cells
Time frame: From the date of registration to 30 days after last trial treatment
Difference in the percentage of ALDH1 positive tumor cells
Time frame: From the date of registration to 30 days after last trial treatment
Pathological residual disease
Time frame: From the date of registration to 30 days after last trial treatment
Radiological tumor shrinkage
Time frame: From the date of registration to 30 days after last trial treatment
Breast conservation rate
Time frame: From the date of registration to 30 days after last trial treatment
Doxycycline adherence rate
Time frame: From the date of registration to 30 days after last trial treatment
Patient-reported treatment burden
Time frame: From the date of registration to 30 days after last trial treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: No. The translational work will be to better define these stem cells and to grow organoid cultures to study the effects of the different drugs in vitro and will be carried out as part of this trial. Only data from patients who agreed to an additional biopsy of tumour tissue will be used for translational research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Loïc Lelièvre, M.D. study chair
Centre hospitalier universitaire vaudois (CHUV)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxycyclin in people with Breast Cancer, run by Swiss Cancer Institute at 8 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniela Zoelly, PhD (+41 31 389 91 91, trials@swisscancerinstitute.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the proportion of patients with ALDH1 positive tumors before and after neoadjuvant chemotherapy plus doxycycline. (time frame: From the date of registration to 30 days after last trial treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.