Trial · NCT00096109
Tanespimycin in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer
NCT00096109, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2017-01-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tanespimycin in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer. Trials, record NCT00096109. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00096109
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tanespimycin in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer
- NCT number
- NCT00096109
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
- Interventions
- tanespimycin, laboratory biomarker analysis
- First posted
- 2004-11-09
- Last updated
- 2017-01-16
- Results first posted
- 2017-01-16
- Limitations and caveats
Because of the frequency of toxicities experienced by the pts \& lack of response, study closed to accrual before all 17 planned pts were enrolled. It was proposed to analyze outcome by HER2 status,but no HER2 data was collected.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate (Complete Response (CR) +Partial Response (PR) | Up to 7 years | 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. |
| Primary | Progression Free Survival (PFS) | Up to 7 years | PFS is defined as either progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Primary | Her2/Neu Status | Baseline | Response rates will be estimated separately for her2/neu positive and her2/neu negative individuals along with 95% confidence intervals. PLEASE NOTE: IT WAS PROPOSED TO ANALYZE OUTCOME BY HER2 STATUS, NO DATA WAS COLLECTED OR EVALUATED. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate (Complete Response (CR) +Partial Response (PR) | Up to 7 years | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Progression Free Survival (PFS) | Up to 7 years | months | MEDIAN | |
| PRIMARY | Her2/Neu Status | Baseline | No participants were evaluated for her2/neu status. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate (Complete Response (CR) +Partial Response (PR) | Treatment (Tanespimycin) | 0 | Participants | ||
| Progression Free Survival (PFS) | Treatment (Tanespimycin) | 2 | 95% Confidence Interval 1 to 11 | months |
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 | Treatment (Tanespimycin) | 11 | |
| Overall Study | COMPLETED | Treatment (Tanespimycin) | 11 | |
| Overall Study | NOT COMPLETED | Treatment (Tanespimycin) | 0 |
Source ClinicalTrials.gov
Adverse events58
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 | Anemia | Blood and lymphatic system disorders | Treatment (Tanespimycin) | 7 | 11 | 11 |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Tanespimycin) | 4 | 11 | 6 |
| other | Sinus Tachycardia | Cardiac disorders | Treatment (Tanespimycin) | 1 | 11 | 1 |
| other | Vomiting | Gastrointestinal disorders | Treatment (Tanespimycin) | 1 | 11 | 1 |
| other | Edema Limbs | General disorders | Treatment (Tanespimycin) | 1 | 11 | 1 |
| other | Lymphocyte Count Decreased | Investigations | Treatment (Tanespimycin) | 3 | 11 | 3 |
| other | Blood Bilirubin Increased | Investigations | Treatment (Tanespimycin) | 2 | 11 | 2 |
| other | Alanine Aminotransferase Increased | Investigations | Treatment (Tanespimycin) | 3 | 11 | 4 |
| other | Aspartate Aminotransferase | Investigations | Treatment (Tanespimycin) | 5 | 11 | 7 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Treatment (Tanespimycin) | 4 | 11 | 7 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Tanespimycin) | ||
| Total, other adverse events | Treatment (Tanespimycin) | 9 | 11 |
| Total, serious adverse events | Treatment (Tanespimycin) | 6 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U01CA062487 | Early Clinical Trials of New Anti-Cancer Agents | LORUSSO, PATRICIA M. | WAYNE STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1994 to 2013 | NIH RePORTER |
| U01CA062502 | Early Clinical Trials of New Anti-Cancer Agents with Phase I Emphasis | DOWLATI, AFSHIN | CASE WESTERN RESERVE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1994 to 2013 | 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/NCT00096109
GET https://conductscience.org/api/trials/v1/NCT00096109/events?page=2