Breast CarcinomaPhase 2NCT02874430
Metformin Hydrochloride and Doxycycline in Treating Patients With Localized Breast or Uterine Cancer
A Phase 2 study testing Metformin Hydrochloride and Doxycycline in people with Breast Carcinoma and Endometrial Clear Cell Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
This phase II trial studies how well metformin hydrochloride works together with doxycycline in treating patients with localized breast or uterine cancer. Metformin hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma
- What is being tested?
- Metformin Hydrochloride and Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2016to 11 Dec 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible for participation in this trial, the subject must:
- Diagnosis of localized breast or uterine cancer that is either biopsy proven or suspected based on history, physical, and or radiographic findings, and who are planned for definitive resection of the tumor without the use of neoadjuvant chemotherapy or radiation therapy at TJUH are eligible to participate.
- Subjects must be ≥ 18 years of age at time of consent.
- Subjects must be newly diagnosed or suspected to have breast, uterine (endometrial cancer with histologies including endometrioid, serous, clear cell, and carcinosarcoma) or cervical cancer.
- Patient must be able to swallow pills.
- Patients with serum creatinine levels less than 1.5 mg/dL.
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- Women of child bearing potential must have a negative urine or blood pregnancy test within 14 days of study enrollment.
- Informed Consent: All subjects must be able to comprehend and sign a written informed consent document.
- ECOG Performance status <1
Who cannot join
- The subject must be excluded from participating in the trial if the subject:
- Received any prior cancer therapy for the breast or uterine cancer that is being resected, including progesterone therapy for endometrial cancer patients.
- Patients may have had prior therapy for other contra-lateral breast cancer.
- Subjects who are pregnant or breastfeeding or may become pregnant during metformin and doxycycline administration.
- Subjects on metformin or doxycycline for any reason during the preceding 4 weeks.
- Diabetic subjects that are managed by taking metformin or insulin.
Show all 21Show fewer
- Subjects who have received iodinated contrast dye must wait 12 hours prior to starting Metformin. If a CT scan with contrast is scheduled after screening and consent, the metformin cannot be taken until after the CT with contrast has been completed and they have waited 12 hours.
- Patients with serum creatinine level greater than 1.5 mg/dL.
- Patients with history of lactic or any other metabolic acidosis.
- Patients with history of congestive heart failure stage III or greater.
- Patients scheduled for definitive cancer surgical resection less than 7 days from beginning of study drug administration or greater than 6 weeks from beginning study drug administration.
- Patients with history of hepatic dysfunction or hepatic disease and abnormal liver function tests defined as AST, ALT, Alk Phos, and or total bilirubin greater than 2.5 times the upper limit of normal.
- Patients who have a history of hepatic dysfunction or hepatic disease and normal liver function tests will be eligible to participate.
- Patients with a current history (in the past 30 days) of heavy drinking which is defined in accordance with CDC definition as more than 8 drinks per week for women and more than 15 drinks per week for men. A standard drink contains .6 ounces of pure alcohol. Generally, this amount of pure alcohol is found in 12-ounces of beer, 8-ounces of malt liquor, 5-ounces of wine, 1.5-ounces or a "shot" of 80-proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey). While on study, patients should limit their alcohol consumption to no more than 8 drinks per week for women and no more than 15 drinks per week for men. Patients who feel they cannot comply with this recommendation are not eligible.
- Prior allergic reaction to metformin, doxycycline, or any other tetracycline antibiotic in the past.
- Patient is on medications that are contraindicated with metformin or doxycycline under current FDA recommendations. The following is a list of medications identified as class D (consider therapy modification) when treatment with metformin or doxycycline is considered:
- Class D:
- Bismuth Subsalicylate
- Cimetidine
- Iodinated contrast agents
- Somatropin
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Phase II Study of Metformin in Combination With Doxycycline in Patients With Localized Breast, and Uterine, and Cervical Cancer
This phase II trial studies how well metformin hydrochloride works together with doxycycline in treating patients with localized breast or uterine cancer. Metformin hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Doxycycline may stop the growth of bacteria by keeping them from making proteins and minimized the toxic side effects of anti-cancer therapy. It is not yet known whether giving metformin hydrochloride together with doxycycline may be a better way in treating patients with localized breast or uterine cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if treatment with a combination of metformin and doxycycline can increase the percentage of cells that express Caveolin-1 in the cancer associated fibroblasts of patients with breast, or uterine, and cervical cancers.
SECONDARY OBJECTIVES:
- To determine the effect of metformin and doxycycline treatment on the percentage of cells that express monocarboxylate transporter (MCT)4 in cancer associated fibroblasts and MCT1 and transporter of outer mitochondrial membrane (TOMM)20 in the cancer cells of breast and uterine cancer patients.
II. To assess safety and tolerability of metformin and doxycycline treatment in subjects with breast and uterine cancer.
III. To determine the relationship of the percentage of stromal cells expressing caveolin (CAV)1 or MCT4 and tumor cells that express MCT1 and TOMM20 at baseline and after treatment with metformin and doxycycline with the percentage of cells expressing estrogen receptor (ER) and progesterone receptor (PR) for breast and uterine samples and human epidermal growth factor (HER)2 in breast cancer samples.
TERTIARY OBJECTIVES:
- To assess the effect of combined metformin and doxycycline therapy on the metabolic profile of cancer cells and stroma using mass spectroscopy imaging (MSI) on paired samples, comparing metabolite profiles in the pre-metformin and post-metformin tumor sample.
II. To assess, when possible, the impact of a patient's nutritional status, estimated using 3 day dietary recall versus caloric needs as calculated by the Harris-Benedict equation on the baseline and net change in CAV1 III. To assess the effect of combined metformin and doxycycline therapy on oncomiR micro ribonucleic acid (RNA) (miR-21) after intervention.
IV. To assess the effect of combined metformin and doxycycline therapy on adipokines and the insulin-like growth factor (IGF)-1/insulin signaling pathways through assessment of serum triglycerides, IGF-1, IGF-binding protein (BP)3, erythrocyte sedimentation rate (ESR), adiponectin, leptin, IGF-1 receptor (R), exosome evaluation, metabolomics profile, and microRNA expression profile.
- Conditions
- Breast Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Uterine Corpus Cancer, Uterine Corpus Carcinosarcoma
- Being tested
- Metformin Hydrochloride, Doxycycline
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin HydrochlorideDrug
Also called 1,1-Dimethylbiguanide Hydrochloride, 1115-70-4, 91485, Cidophage
Given orally
DoxycyclineDrug
Also called 17086-28-1, Doxycycline Monohydrate
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Treatment (metformin hydrochloride, doxycycline) | Experimental | Patients receive metformin hydrochloride orally daily on days 1-3 and twice a day starting on day 4. Patients also receive doxycycline orally every 12 hours starting on day 1. Treatment repeats every 7 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Metformin Hydrochloride; Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Percentage of Stromal Cells Expressing Caveolin-1 (CAV1) at an Intensity of 1+ or Greater by Immunohistochemistry
Caveolin-1 (CAV1) expression in stromal cells is assessed by immunohistochemistry using a standard intensity scale of 0 to 3+, where 0 indicates no staining and 1+, 2+, and 3+ indicate increasing levels of staining intensity. For this measure, stromal cells with CAV1 staining of 1+ or higher are considered positive. Results are reported as the percentage of positive stromal cells, ranging from 0% (no positive cells) to 100% (all cells positive). Higher percentages indicate a worse outcome, as higher CAV1 expression is associated with more aggressive tumor behavior. Within-patient changes will be analyzed using the Wilcoxon signed-rank test.
Measured: Pre-treatment (Baseline) and Post-treatment (week 6)
Secondary outcomes (8)
Number of Adverse Events
Incidence of adverse events evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Measured: 12 months
Change in the Percent of Stromal Cells Expressing Express Monocarboxylate Transporter 4 (MCT4) in the Cancer Cells
Analysis will be performed separately in breast and uterine cancer patients. Evaluated using Aperio analyses of expression intensity with previously validated algorithms. Analysis will be performed using the Wilcoxon signed-rank test.
Measured: at 5 weeks
Percent of Tumor Cells That Express Transporter of Outer Mitochondrial Membrane 20 (TOMM20) in the Cancer Cells
Analysis was performed in breast and uterine cancer patients together due to lower than expected tumor viability.
Measured: at 5 weeks
Percentage of Stromal Cells Expressing Caveolin-1 (CAV1) or Monocarboxylate Transporter 4 (MCT4)
Assessed in relation to the percentage of cells expressing Estrogen Receptor (ER) and Progesterone Receptor (PR) for breast and uterine samples and Human Epidermal Growth Factor Receptor 2 (HER2) in breast cancer samples.
Measured: 5 weeks
Percentage of Tumor Cells That Express Monocarboxylate Transporter 1 (MCT1)
Analyzed breast and uterine cancer patients together due to low tumor viability. Mean scores and full range are provided. Expression is reported as the percentage of tumor cells staining on a positive scale from 0-100%, where higher percentages indicate greater MCT1 expression. Pre-treatment and post treatment samples were compared.
Measured: Pre-treatment (Baseline) and Post-treatment (week 6)
Progression-free Survival
The time from the start of treatment until disease progression or death from any cause, whichever occurs first. The number of participants who experienced progression or death during the follow up period is reported.
Measured: 1 year
Overall Survival (OS)
The time from the start of treatment until death from any cause. The number of participants who died during the 12 month follow up period.
Measured: 12 months
Clinical Response Rate
The number of participants with clinical improvement in disease status following treatment. Clinical response is defined as the continued eligibility for the surgical procedure as initially planned at the time of trial enrollment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study start8 Jun 2016
- Primary completion11 Dec 2020
- Study completion11 Dec 2020
Why it stopped: study closed early due to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CarcinomaStudies 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
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Johnson, MD, PhD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874430
- Sponsor's protocol ID
- 16D.317
- Other IDs
- JT 8988
- Status last verified
- Mar 2026
- First submitted
- 17 Aug 2016
- Last updated
- 22 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Metformin in Combination With Doxycycline in Patients With Localized Breast, and Uterine, and Cervical Cancer
- ClinicalTrials.gov ID
- NCT02874430
- Acronym / sponsor ID
- 16D.317
- Conditions
- Breast Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Uterine Corpus Cancer, Uterine Corpus Carcinosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study closed early due to slow accrual
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Posted 22 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well metformin hydrochloride works together with doxycycline in treating patients with localized breast or uterine cancer. Metformin hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Doxycycline may stop the growth of bacteria by keeping them from making proteins and minimized the toxic side effects of anti-cancer therapy. It is not yet known whether giving metformin hydrochloride together with doxycycline may be a better way in treating patients with localized breast or uterine cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine if treatment with a combination of metformin and doxycycline can increase the percentage of cells that express Caveolin-1 in the cancer associated fibroblasts of patients with breast, or uterine, and cervical cancers.
SECONDARY OBJECTIVES:
- To determine the effect of metformin and doxycycline treatment on the percentage of cells that express monocarboxylate transporter (MCT)4 in cancer associated fibroblasts and MCT1 and transporter of outer mitochondrial membrane (TOMM)20 in the cancer cells of breast and uterine cancer patients.
II. To assess safety and tolerability of metformin and doxycycline treatment in subjects with breast and uterine cancer.
III. To determine the relationship of the percentage of stromal cells expressing caveolin (CAV)1 or MCT4 and tumor cells that express MCT1 and TOMM20 at baseline and after treatment with metformin and doxycycline with the percentage of cells expressing estrogen receptor (ER) and progesterone receptor (PR) for breast and uterine samples and human epidermal growth factor (HER)2 in breast cancer samples.
TERTIARY OBJECTIVES:
- To assess the effect of combined metformin and doxycycline therapy on the metabolic profile of cancer cells and stroma using mass spectroscopy imaging (MSI) on paired samples, comparing metabolite profiles in the pre-metformin and post-metformin tumor sample.
II. To assess, when possible, the impact of a patient's nutritional status, estimated using 3 day dietary recall versus caloric needs as calculated by the Harris-Benedict equation on the baseline and net change in CAV1 III. To assess the effect of combined metformin and doxycycline therapy on oncomiR micro ribonucleic acid (RNA) (miR-21) after intervention.
IV. To assess the effect of combined metformin and doxycycline therapy on adipokines and the insulin-like growth factor (IGF)-1/insulin signaling pathways through assessment of serum triglycerides, IGF-1, IGF-binding protein (BP)3, erythrocyte sedimentation rate (ESR), adiponectin, leptin, IGF-1 receptor (R), exosome evaluation, metabolomics profile, and microRNA expression profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (metformin hydrochloride, doxycycline) | Experimental | Drug: Metformin Hydrochloride, Drug: DoxycyclinePatients receive metformin hydrochloride orally daily on days 1-3 and twice a day starting on day 4. Patients also receive doxycycline orally every 12 hours starting on day 1. Treatment repeats every 7 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of localized breast or uterine cancer that is either biopsy proven or suspected based on history, physical, and or radiographic findings, and who are planned for definitive resection of the tumor without the use of neoadjuvant chemotherapy or radiation therapy at TJUH are eligible to participate.
- Subjects must be ≥ 18 years of age at time of consent.
- Subjects must be newly diagnosed or suspected to have breast, uterine (endometrial cancer with histologies including endometrioid, serous, clear cell, and carcinosarcoma) or cervical cancer.
- Patient must be able to swallow pills.
- Patients with serum creatinine levels less than 1.5 mg/dL.
Key exclusion criteria (21 listed)
- Received any prior cancer therapy for the breast or uterine cancer that is being resected, including progesterone therapy for endometrial cancer patients.
- Subjects who are pregnant or breastfeeding or may become pregnant during metformin and doxycycline administration.
- Subjects on metformin or doxycycline for any reason during the preceding 4 weeks.
- Diabetic subjects that are managed by taking metformin or insulin.
- Subjects who have received iodinated contrast dye must wait 12 hours prior to starting Metformin. If a CT scan with contrast is scheduled after screening and consent, the metformin cannot be taken until after the CT with contrast has been completed and they have waited 12 hours.
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 |
|---|---|---|
| Metformin HydrochlorideAlso: 1,1-Dimethylbiguanide Hydrochloride, 1115-70-4, 91485, CidophageGiven orally | Drug | Treatment (metformin hydrochloride, doxycycline) |
| DoxycyclineAlso: 17086-28-1, Doxycycline MonohydrateGiven orally | Drug | Treatment (metformin hydrochloride, doxycycline) |
Primary outcome
Change in the Percentage of Stromal Cells Expressing Caveolin-1 (CAV1) at an Intensity of 1+ or Greater by Immunohistochemistry
Time frame: Pre-treatment (Baseline) and Post-treatment (week 6)
Caveolin-1 (CAV1) expression in stromal cells is assessed by immunohistochemistry using a standard intensity scale of 0 to 3+, where 0 indicates no staining and 1+, 2+, and 3+ indicate increasing levels of staining intensity. For this measure, stromal cells with CAV1 staining of 1+ or higher are considered positive. Results are reported as the percentage of positive stromal cells, ranging from 0% (no positive cells) to 100% (all cells positive). Higher percentages indicate a worse outcome, as higher CAV1 expression is associated with more aggressive tumor behavior. Within-patient changes will be analyzed using the Wilcoxon signed-rank test.
8 secondary outcomes
Number of Adverse Events
Time frame: 12 months
Change in the Percent of Stromal Cells Expressing Express Monocarboxylate Transporter 4 (MCT4) in the Cancer Cells
Time frame: at 5 weeks
Percent of Tumor Cells That Express Transporter of Outer Mitochondrial Membrane 20 (TOMM20) in the Cancer Cells
Time frame: at 5 weeks
Percentage of Stromal Cells Expressing Caveolin-1 (CAV1) or Monocarboxylate Transporter 4 (MCT4)
Time frame: 5 weeks
Percentage of Tumor Cells That Express Monocarboxylate Transporter 1 (MCT1)
Time frame: Pre-treatment (Baseline) and Post-treatment (week 6)
Progression-free Survival
Time frame: 1 year
Overall Survival (OS)
Time frame: 12 months
Clinical Response Rate
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Thomas Jefferson University HospitalLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Jennifer Johnson, MD, PhD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin Hydrochloride and Doxycycline in people with Breast Carcinoma and Endometrial Clear Cell Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
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 9 inclusion and 21 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: stopped early, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 22 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Percentage of Stromal Cells Expressing Caveolin-1 (CAV1) at an Intensity of 1+ or Greater by Immunohistochemistry (time frame: Pre-treatment (Baseline) and Post-treatment (week 6)). 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 22 Apr 2026.