NCT00244933

Phase II Trial of Gemcitabine and Genistein in Metastatic Breast Cancer Patients With Biomarker Assays

Completed Phase 2 Results posted Last updated 22 May 2023

What this trial tests

Phase 2 trial testing genistein in Breast Cancer in 19 participants. Completed in 1 October 2009.

Timeline

1 February 2004

Primary endpoint
1 November 2008

1 October 2009

Quick facts

Lead sponsor	Barbara Ann Karmanos Cancer Institute
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	1 February 2004
Primary completion	1 November 2008
Estimated completion	1 October 2009
Sites	1 location across United States

Drugs / interventions tested

• genistein — full drug profile →
• gemcitabine (gemcitabine) — full drug profile →
• Tumor biopsy

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Barbara Ann Karmanos Cancer Institute

Who can join

Adults 18 to 120, female only, with Breast Cancer. 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.

• Objective Response Rate by RECIST Criteria Following
  Time frame: every 2 courses until disease progression or death, up to 24 weeks
  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Sponsor's own description

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and genistein, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine hydrochloride together with genistein may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine hydrochloride together with genistein works in treating women with stage IV breast cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Perspectives for cancer prevention with natural compounds.
   Amin AR, Kucuk O, Khuri FR, Shin DM. · · 2009 · cited 330× · PMID 19414669 · DOI 10.1200/jco.2008.20.6235
2. Overcoming cancer therapeutic bottleneck by drug repurposing.
   Zhang Z, Zhou L, Xie N, Nice EC, et al · · 2020 · cited 328× · PMID 32616710 · DOI 10.1038/s41392-020-00213-8
3. Natural Products as Anticancer Agents: Current Status and Future Perspectives.
   Naeem A, Hu P, Yang M, Zhang J, et al · · 2022 · cited 292× · PMID 36500466 · DOI 10.3390/molecules27238367
4. Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
   Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3
5. Drug repurposing for cancer therapy.
   Xia Y, Sun M, Huang H, Jin WL. · · 2024 · cited 229× · PMID 38637540 · DOI 10.1038/s41392-024-01808-1
6. Recent progress in DNA methyltransferase inhibitors as anticancer agents.
   Zhang Z, Wang G, Li Y, Lei D, et al · · 2022 · cited 96× · PMID 37077808 · DOI 10.3389/fphar.2022.1072651
7. Regulation of microRNAs by natural agents: new strategies in cancer therapies.
   Phuah NH, Nagoor NH. · · 2014 · cited 90× · PMID 25254214 · DOI 10.1155/2014/804510
8. Harnessing the fruits of nature for the development of multi-targeted cancer therapeutics.
   Sarkar FH, Li Y. · · 2009 · cited 88× · PMID 19660870 · DOI 10.1016/j.ctrv.2009.07.001