Trial · NCT00086957
Gefitinib, Trastuzumab, and Docetaxel in Treating Patients With Metastatic Breast Cancer
NCT00086957, Phase 1, Phase 2, Completed, City of Hope Medical Center; results first posted 2017-02-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gefitinib, Trastuzumab, and Docetaxel in Treating Patients With Metastatic Breast Cancer. Trials, record NCT00086957. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00086957
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gefitinib, Trastuzumab, and Docetaxel in Treating Patients With Metastatic Breast Cancer
- NCT number
- NCT00086957
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
- Breast Cancer
- Interventions
- trastuzumab, docetaxel, gefitinib
- First posted
- 2004-07-12
- Last updated
- 2017-02-27
- Results first posted
- 2017-02-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With at Least One Dose Limiting Toxicity in Phase I | 4 weeks from start of treatment, up to 2 years | Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater except for hematological toxicities which must be grade 4. Interstitial Lung Disease (ILD) related to treatment should be considered as a DLT regardless of the grade. |
| Primary | Recommended Phase II Dose | 4 weeks from start of treatment, up to 2 years | The maximum tolerated dose (MTD): subjects received gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m\^2 intravenously every 3 weeks. This was to serve as the phase II dose if no dose-limiting toxicities (DLTs) occurred in the first three subjects. If one DLT occurred in the first three subjects, another three subjects where to be enrolled at this dose, whereas if two DLTs occurred in the first three subjects, the docetaxel dose was to be decreased to 60 mg/m\^2. The study would then be continued only if no more than one patient had a DLT at this dose. Once the dose of docetaxel was established, all further subjects were to be treated at the phase II MTD dose. |
| Secondary | Progression-free Survival | Until disease progression, up to 5 years. | Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions. |
| Secondary | Objective Response Rate | After 3 cycles of treatment, up to 2 years. | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 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; Objective Response Rate defined as percentage of patients achieving a Best Response of either CR or PR. |
| Secondary | Overall Survival | Until death from any cause, up to 5 years. | Estimated using the product-limit method of Kaplan and Meier. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With at Least One Dose Limiting Toxicity in Phase I | 4 weeks from start of treatment, up to 2 years | All patients receiving treatment were evaluated for DLT. | participants with DLTs | NUMBER |
| PRIMARY | Recommended Phase II Dose | 4 weeks from start of treatment, up to 2 years | All patients observed for 21 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced. | mg/m^2 | NUMBER |
| SECONDARY | Progression-free Survival | Until disease progression, up to 5 years. | All patients treated at the phase II docetaxel dose (7 in the phase I portion, 22 in the phase II portion). | Months | MEDIAN |
| SECONDARY | Objective Response Rate | After 3 cycles of treatment, up to 2 years. | All patients treated at the phase II docetaxel dose (7 in the phase I portion, 22 in the phase II portion). Patients who complete 3 cycles of treatment or who terminate treatment for reasons of toxicity, or who progress prior to the completion of 3 cycles of therapy on the Phase II portion of the study. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | Until death from any cause, up to 5 years. | All patients treated at the phase II docetaxel dose (7 in the phase I portion, 22 in the phase II portion). | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With at Least One Dose Limiting Toxicity in Phase I | Phase I: Dose Level 1 - Docetaxel 75 mg/m^2 | 2 | participants with DLTs | ||
| Number of Participants With at Least One Dose Limiting Toxicity in Phase I | Phase I: Dose Level 2 - Docetaxel 60 mg/m^2 | 0 | participants with DLTs | ||
| Recommended Phase II Dose | Phase I | 60 | mg/m^2 | ||
| Progression-free Survival | Dose Level 2 - Docetaxel 60 mg/m^2 | 12.7 | 95% Confidence Interval 7.6 to 21.8 | Months | |
| Objective Response Rate | Dose Level 2 - Docetaxel 60 mg/m^2 | 64 | percentage of participants | ||
| Overall Survival | Dose Level 2 - Docetaxel 60 mg/m^2 | 43.2 | 95% Confidence Interval 30.8 to 65.3 | Months |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I - Docetaxel 75 mg/m^2 | 2 | |
| Overall Study | STARTED | Phase I - Docetaxel 60 mg/m^2 | 7 | |
| Overall Study | STARTED | Phase II - Docetaxel 60 mg/m^2 | 22 | |
| Overall Study | COMPLETED | Phase I - Docetaxel 75 mg/m^2 | 2 | |
| Overall Study | COMPLETED | Phase I - Docetaxel 60 mg/m^2 | 7 | |
| Overall Study | COMPLETED | Phase II - Docetaxel 60 mg/m^2 | 22 | |
| Overall Study | NOT COMPLETED | Phase I - Docetaxel 75 mg/m^2 | 0 | |
| Overall Study | NOT COMPLETED | Phase I - Docetaxel 60 mg/m^2 | 0 | |
| Overall Study | NOT COMPLETED | Phase II - Docetaxel 60 mg/m^2 | 0 |
Source ClinicalTrials.gov
Adverse events342
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 | Haematemesis | Gastrointestinal disorders | Dose Level 1 - Docetaxel 75 mg/m^2 | 0 | 2 | 0 |
| other | Haematemesis | Gastrointestinal disorders | Dose Level 2 - Docetaxel 60 mg/m^2 | 1 | 29 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Dose Level 1 - Docetaxel 75 mg/m^2 | 0 | 2 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Dose Level 2 - Docetaxel 60 mg/m^2 | 1 | 29 | 1 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Dose Level 1 - Docetaxel 75 mg/m^2 | 2 | 2 | 9 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Dose Level 2 - Docetaxel 60 mg/m^2 | 25 | 29 | 196 |
| other | Lymphatic disorder | Blood and lymphatic system disorders | Dose Level 1 - Docetaxel 75 mg/m^2 | 0 | 2 | 0 |
| other | Lymphatic disorder | Blood and lymphatic system disorders | Dose Level 2 - Docetaxel 60 mg/m^2 | 9 | 29 | 18 |
| other | Packed red blood cell transfusion | Blood and lymphatic system disorders | Dose Level 1 - Docetaxel 75 mg/m^2 | 0 | 2 | 0 |
| other | Packed red blood cell transfusion | Blood and lymphatic system disorders | Dose Level 2 - Docetaxel 60 mg/m^2 | 1 | 29 | 1 |
1 to 10 of 342Source ClinicalTrials.gov
See all 342 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 1 - Docetaxel 75 mg/m^2 | ||
| Total, all-cause mortality | Dose Level 2 - Docetaxel 60 mg/m^2 | ||
| Total, other adverse events | Dose Level 1 - Docetaxel 75 mg/m^2 | 2 | 2 |
| Total, other adverse events | Dose Level 2 - Docetaxel 60 mg/m^2 | 29 | 29 |
| Total, serious adverse events | Dose Level 1 - Docetaxel 75 mg/m^2 | 2 | 2 |
| Total, serious adverse events | Dose Level 2 - Docetaxel 60 mg/m^2 | 7 | 29 |
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 |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dose Level 1 - Docetaxel 75 mg/m^2 vs Dose Level 2 - Docetaxel 60 mg/m^2: serious adverse events |
Source Trial comparisons
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/NCT00086957
GET https://conductscience.org/api/trials/v1/NCT00086957/events?page=2