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NCT02874430
A Phase II Study of Metformin in Combination With Doxycycline in Patients With Localized Breast, and Uterine, and Cervical Cancer
Phase 2 trial testing Metformin Hydrochloride in Breast Carcinoma in 29 participants. Terminated before completion.
11 December 2020
Quick facts
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 29 |
| Start date | 8 June 2016 |
| Primary completion | 11 December 2020 |
| Estimated completion | 11 December 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Metformin Hydrochloride — full drug profile →
- Doxycycline (doxycycline) — full drug profile →
Conditions studied
- Breast Carcinoma — all drugs for Breast Carcinoma →
- Endometrial Clear Cell Adenocarcinoma — all drugs for Endometrial Clear Cell Adenocarcinoma →
- Endometrial Serous Adenocarcinoma — all drugs for Endometrial Serous Adenocarcinoma →
- Uterine Corpus Cancer — all drugs for Uterine Corpus Cancer →
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Who can join
18 and older, female only, with Breast Carcinoma or Endometrial Clear Cell Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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%
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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The updated landscape of tumor microenvironment and drug repurposing.
Jin MZ, Jin WL. · · 2020 · cited 900× · PMID 32843638 · DOI 10.1038/s41392-020-00280-x -
Reactive Oxygen Species in the Tumor Microenvironment: An Overview.
Weinberg F, Ramnath N, Nagrath D. · · 2019 · cited 301× · PMID 31426364 · DOI 10.3390/cancers11081191 -
Stromal Modulators of TGF-β in Cancer.
Costanza B, Umelo IA, Bellier J, Castronovo V, et al · · 2017 · cited 129× · PMID 28067804 · DOI 10.3390/jcm6010007 -
New drugs are not enough‑drug repositioning in oncology: An update.
Armando RG, Mengual Gómez DL, Gomez DE. · · 2020 · cited 72× · PMID 32124955 · DOI 10.3892/ijo.2020.4966 -
Metformin: The Answer to Cancer in a Flower? Current Knowledge and Future Prospects of Metformin as an Anti-Cancer Agent in Breast Cancer.
Samuel SM, Varghese E, Kubatka P, Triggle CR, et al · · 2019 · cited 58× · PMID 31835318 · DOI 10.3390/biom9120846 -
Metformin as a Therapeutic Target in Endometrial Cancers.
Lee TY, Martinez-Outschoorn UE, Schilder RJ, Kim CH, et al · · 2018 · cited 52× · PMID 30211120 · DOI 10.3389/fonc.2018.00341 -
Repurposing non-oncology small-molecule drugs to improve cancer therapy: Current situation and future directions.
Fu L, Jin W, Zhang J, Zhu L, et al · · 2022 · cited 47× · PMID 35256933 · DOI 10.1016/j.apsb.2021.09.006 -
Therapeutic Repurposing of Biguanides in Cancer.
Zhao H, Swanson KD, Zheng B. · · 2021 · cited 47× · PMID 33865798 · DOI 10.1016/j.trecan.2021.03.001
Verify or expand the search:
- PubMed search for NCT02874430
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Breast Carcinoma
Currently open trials in the same condition.
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Other Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University trials
Trials by the same sponsor.
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- NCT03796884 — Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer · Phase 2 · active not recruiting
- NCT03712904 — Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma · Phase 2 · terminated
- NCT03807492 — Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWeR) · completed
- NCT03477864 — Stereotactic Body Radiation Therapy With REGN2810 and/or Ipilimumab Before Surgery in Treating Participants With Progres · Phase 1 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02874430 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Last refreshed: 31 March 2026
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