Table 5.
Metformin Adjuvant Trials (N=20)
| Organ Site; Phase; ClinicalTrials.gov, EudraCT or ICTRP Number, Status | Study Design | Study Population | Target Accrual | Primary Endpoint |
|---|---|---|---|---|
| All Phase I NCT01981525, R | 500mg qd for 1week, 500mg bid for 1 wk, 500mg tid for 1 week and 1000mg bid for 1 wk if tolerated continued treatment for 14 weeks | TP53 germline mutation at least 18 yrs old. If prior cancer at least 6 months from surgery and 1 year from chemotherapy | 36 | Tolerability and effect on IGF-1, insulin, IGFBP-3 |
| Breast Phase II NCT01302379, R | Exercise, exercise + metformin 500mg at dinner (1 weeks) 1000mg at dinner (2-4 weeks) 500mg in morning and 1000mg at dinner, metformin + standard dietary guidelines, Vs. dietary guidelines for 6 months | Postmenopausal IBC survivor Stage 1-3A within past 4 yrs, completed chemotherapy, BMI ≥ 25 | 340 | Biological markers associated with breast cancer survival |
| Breast Phase II NCT00909506, U | 500mg/d vs 1000mg/d vs. Placebo for 6 months | BC survivor with BMI ≥ 23 6-24 months since surgery and 4 weeks since chemotherapy or radiation | 105 | Weight loss |
| Breast Phase III (MA.32) NCT01101438, O | 850mg bid vs. Placebo for 5 yrs (850mg qd for first 4 weeks) | IBC Survivor 4 weeks post therapy | 3649 | Invasive disease-free survival |
| Breast Phase III NCT01666171, U | Ancillary study to MA.32 | ER-negative IBC with 25% or greater MD with contralateral breast available for analysis | 458 | Change in % mammographic density |
| Breast Phase III NCT01286233, O | Ancillary Study to MA.32 | DNA available | 394 | QoL |
| Breast Pilot NCT02278965, R | 850mg bid metformin and 1120mg bid omega-3 fatty acids | History of Stage 0-III breast cancer, 6 months since completion of chemotherapy, biologic therapy, and tamoxifen | 20 | Number of participants completing 1 year intervention |
| Colon/ Breast Phase II NCT01340300, R | Exercise, exercise + metformin 850mg qd for 2weeks then 850mg bid metformin, vs. educational information for 1 year | Stage 1-3 breast or colorectal cancer survivor completed all adjuvant therapy within 2-24 months prior to enrollment | 200 | Change in fasting insulin levels at 6 months |
| Endometrial Pilot JPRN-UMIN000002210, C | 400mg/d MPA, 100mg/d aspirin for 24 weeks with 750mg/d metformin continuously for 4 years (increased to 1500mg/d if no side effects) | Histologically well differentiated EA at presumed stage IA and atypical endometrial hyperplasia | 30 | Recurrence free interval |
| Lung Phase II NCT01717482, R | 850mg qd for 4 weeks followed by 850mg BID for a total of 6 months | Suspected or biopsy proven stage IB-IIIA NSSLC-squamous with coincident bronchial dysplasia or carcinoma in situ in a non-resected region | 24 | Feasibility |
| Prostate Phase II NCT01215032, O | 1000mg bid for 1 year | Castrate resistant prostate cancer minimum PSA of 2.0 ng/mL | 106 | PSA response and PSA difference |
| Prostate Phase II NCT01561482, T | 500mg bid escalated to 1000mg bid metformin plus 20mg simvastatin qd for 6 months | Biochemical recurrence of prostate cancer with at least 3 PSA rises | 37 | Improvement in PSA doubling time |
| Prostate Phase II NCT01243385, O | 1000mg bid until disease progression, unacceptable toxicity, or refusal | Biochemical recurrence of locally-advanced or metastatic prostate cancer with at least 3 PSA rises | 44 | PFS at 12 weeks |
| Prostate Phase II NCT01620593, R | 500mg tid vs. placebo for 1 year | Men with locally-advanced or metastatic prostate cancer planning on castration therapy | 94 | Metabolic Syndrome PSA response, progression, pathway inhibition in PBMCs |
| Prostate Phase II NCT02176161, R | 750mg bid for 9 months | Prostate cancer patients who have received treatment with radiation or surgery | 70 | PSA Doubling time |
| Prostate Phase II NCT01996696, R | 500mg tid vs placebo for 3 years | Pathologically confirmed prostate adenocarcinoma with at least 1 high risk feature | 104 | Mean body weight at 12 months |
| Prostate Phase II NCT02420652, NO | Metformin bid and aspirin qd vs. placebo for 6 months | Histologically proven prostate cancer treated with local therapy | 66 | Change in PSA rates |
| Prostate Pilot NCT02376166, R | 850mg bid for 4 weeks | Histologically proven prostate cancer with biochemical progression | 15 | Completion of telemedicine visits |
| Solid Tumors Phase II NCT02431676, NO | Self-directed weight loss, coach directed weight loss Vs. up to 2000mg /d metformin | Previous diagnosis of a solid tumor at least 3 months from therapy | 120 | IGF-1 and IGF-1:IGFBP3 ratio |
| Thyroid Phase II NCT01341886, C | Levothyroxine with 30% dose reduction with either metformin or placebo for 3 months | Papillary or Follicular thyroid cancer with surgery with levothyroxine treatment | 51 | TSH |
R- recruiting, NO- not open yet, C- completed, O- ongoing, not recruiting, T- terminated, U- unknown, qd- one a day, bid- twice a day, tid- three times a day, BMI- body mass index, IBC-invasive breast cancer, ER- estrogen receptor, EA- endometrial adenocarcinoma, NSSLC- non-small cell lung cancer, PSA- prostate specific antigen, PFS- progression free survival, MD- mammographic density, IGF-I- insulin-like growth factor 1, IGF-BP3- insulin-like growth factor binding protein 3, QoL- quality of life, MPA- medroxyprogesterone acetate, PBMCs- peripheral blood mononuclear cells, TSH- thyroid stimulating hormone