Trial · NCT00244933
Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer
NCT00244933, Phase 2, Completed, Barbara Ann Karmanos Cancer Institute; results first posted 2015-02-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer. Trials, record NCT00244933. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00244933
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer
- NCT number
- NCT00244933
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Conditions
- Breast Cancer
- Interventions
- genistein, gemcitabine, Tumor biopsy
- First posted
- 2005-10-27
- Last updated
- 2023-06-22
- Results first posted
- 2015-02-02
- Limitations and caveats
- Although the study is designed to accrue 18 response evaluable participants in the first stage, the decision was made to close the study after 17 patients because of lack of efficacy.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate by RECIST Criteria Following | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate by RECIST Criteria Following | every 2 courses until disease progression or death, up to 24 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate by RECIST Criteria Following | Gemcitabine & Genistein | 0 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gemcitabine, Genistein (Novasoy), Tumor Biopsy | 19 | |
| Overall Study | COMPLETED | Gemcitabine, Genistein (Novasoy), Tumor Biopsy | 17 | |
| Overall Study | NOT COMPLETED | Gemcitabine, Genistein (Novasoy), Tumor Biopsy | 2 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hemoglobin (Hgb) | Investigations | Gemcitabine & Genistein | 1 | 19 | 1 |
| other | Platelets | Investigations | Gemcitabine & Genistein | 1 | 19 | 1 |
| other | Fatigue | General disorders | Gemcitabine & Genistein | 2 | 19 | 2 |
| other | Vomiting | Gastrointestinal disorders | Gemcitabine & Genistein | 1 | 19 | 1 |
| other | Elevated Alkaline Phosphate | Investigations | Gemcitabine & Genistein | 1 | 19 | 1 |
| other | Pain | General disorders | Gemcitabine & Genistein | 2 | 19 | 2 |
| other | Hot flashes | Vascular disorders | Gemcitabine & Genistein | 1 | 19 | 1 |
| other | Rash | Skin and subcutaneous tissue disorders | Gemcitabine & Genistein | 1 | 19 | 1 |
| serious | White blood cells (WBC) | Investigations | Gemcitabine & Genistein | 5 | 19 | 5 |
| serious | Hemoglobin (Hgb) | Investigations | Gemcitabine & Genistein | 1 | 19 | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gemcitabine & Genistein | ||
| Total, other adverse events | Gemcitabine & Genistein | 2 | 19 |
| Total, serious adverse events | Gemcitabine & Genistein | 5 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA022453 | CANCER CENTER SUPPORT GRANT | PASCHE, BORIS | WAYNE STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00244933
GET https://conductscience.org/api/trials/v1/NCT00244933/registered