Trial · NCT00493870
TAC Versus TC for Adjuvant Breast Cancer
NCT00493870, Phase 3, Completed, US Oncology Research; results first posted 2023-03-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. TAC Versus TC for Adjuvant Breast Cancer. Trials, record NCT00493870. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00493870
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TAC Versus TC for Adjuvant Breast Cancer
- NCT number
- NCT00493870
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,961 participants, actual
- Lead sponsor
- US Oncology Research
- Conditions
- Breast Cancer
- Interventions
- Docetaxel, Doxorubicin, Cyclophosphamide
- First posted
- 2007-06-28
- Last updated
- 2023-03-02
- Results first posted
- 2023-03-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 3-year Invasive Disease-free Survival (IDFS) Among Analyzed ITT Patients | 3 years from randomization into study | The primary objective of the study is to compare the 3-year invasive disease-free survival (IDFS) of adjuvant TC versus TAC as treatment for early stage HER2-negative breast cancer among analyzed ITT patients. ITT patients are all patients who were randomized, whether or not they followed protocol. IDFS, defined as the time from the date of randomization to local recurrence following mastectomy, invasive local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, invasive contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer. Patients who have not had any such event at the time of data analysis will be censored at the last date they were known to be event-free. |
| Primary | 3-year Invasive Disease-free Survival (IDFS) Among Per-protocol Patients | 3 years from randomization into study | The primary objective of the study is to compare the 3-year invasive disease-free survival (IDFS) of adjuvant TC versus TAC as treatment for early stage HER2-negative breast cancer among per-protocol patients. Per-protocol only includes those patients who were randomized and received treatment as outlined in the protocol. |
| Secondary | 3-year DFS-DCIS, OS and RFI Among Analyzed ITT Patients | 3 years from randomization into study | To compare disease-free survival-ductal carcinoma in situ (DFS-DCIS),overall survival (OS) and recurrence free interval (RFI) of TC with TAC. DFS-DCIS, defined as the time from the date of randomization to local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy (invasive or non-invasive), regional recurrence, distant recurrence, contralateral breast cancer (invasive or non-invasive), second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer. Patients who have not had any such event at the time of data analysis will be censored at the last date they were known to be event-free. |
| Secondary | 3-year DFS-DCIS, OS and RFI Among Per-protocol Patients. | 3 years from randomization into study | To compare disease-free survival-ductal carcinoma in situ (DFS-DCIS),overall survival (OS) and recurrence free interval (RFI) of TC with TAC among per protocol patients. |
| Secondary | Number and Frequency of Participants by TOP2A Status by Study Treatment | 10 years (from baseline to end of study participation) | To evaluate the effectiveness of TC and TAC in TOP2A altered (amplified, deleted, or overexpressed at the protein level) early stage HER2-negative breast cancer |
| Secondary | 3-year DFS Stratified by TOP2A Among TC Arm | 3 years from randomization into study | To evaluate DFS among TC in TOP2A altered (amplified, deleted, or overexpressed at the protein level) early stage HER2-negative breast cancer. |
| Secondary | 3-year DFS Stratified by TOP2A Among TAC Arm | 3 years from randomization into study | To evaluate DFS among TAC in TOP2A altered (amplified, deleted, or overexpressed at the protein level) early stage HER2-negative breast cancer. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 3-year Invasive Disease-free Survival (IDFS) Among Analyzed ITT Patients | 3 years from randomization into study | Analyzed ITT population | percentage of participants | NUMBER |
| PRIMARY | 3-year Invasive Disease-free Survival (IDFS) Among Per-protocol Patients | 3 years from randomization into study | Per-protocol patients | percentage of participants | NUMBER |
| SECONDARY | 3-year DFS-DCIS, OS and RFI Among Analyzed ITT Patients | 3 years from randomization into study | Analyzed ITT population | percentage of participants | NUMBER |
| SECONDARY | 3-year DFS-DCIS, OS and RFI Among Per-protocol Patients. | 3 years from randomization into study | Analyzed per-protocol patients | percentage of participants | NUMBER |
| SECONDARY | Number and Frequency of Participants by TOP2A Status by Study Treatment | 10 years (from baseline to end of study participation) | Analyzed ITT patients with TOP2A data | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 3-year DFS Stratified by TOP2A Among TC Arm | 3 years from randomization into study | Analyzed ITT patients with TOP2A data | percentage of participants | NUMBER |
| SECONDARY | 3-year DFS Stratified by TOP2A Among TAC Arm | 3 years from randomization into study | Analyzed ITT patients with TOP2A data among TAC arm. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 3-year Invasive Disease-free Survival (IDFS) Among Analyzed ITT Patients | TC Arm | 91.1 | 95% Confidence Interval 89.1 to 92.8 | percentage of participants | |
| 3-year Invasive Disease-free Survival (IDFS) Among Analyzed ITT Patients | TAC Arm | 93.2 | 95% Confidence Interval 91.3 to 94.6 | percentage of participants | |
| 3-year Invasive Disease-free Survival (IDFS) Among Per-protocol Patients | TC Arm | 91.3 | 95% Confidence Interval 89.3 to 93.0 | percentage of participants | |
| 3-year Invasive Disease-free Survival (IDFS) Among Per-protocol Patients | TAC Arm | 93.2 | 95% Confidence Interval 91.3 to 94.7 | percentage of participants | |
| 3-year DFS-DCIS, OS and RFI Among Analyzed ITT Patients | TC Arm | 3-year DFS-DCIS | 90.9 | 95% Confidence Interval 88.8 to 92.6 | percentage of participants |
| 3-year DFS-DCIS, OS and RFI Among Analyzed ITT Patients | TAC Arm | 3-year DFS-DCIS | 93.0 | 95% Confidence Interval 91.1 to 94.5 | percentage of participants |
| 3-year DFS-DCIS, OS and RFI Among Analyzed ITT Patients | TC Arm | 3-year OS | 96.8 | 95% Confidence Interval 95.4 to 97.7 | percentage of participants |
| 3-year DFS-DCIS, OS and RFI Among Analyzed ITT Patients | TAC Arm | 3-year OS | 96.8 | 95% Confidence Interval 95.5 to 97.8 | percentage of participants |
| 3-year DFS-DCIS, OS and RFI Among Analyzed ITT Patients | TC Arm | 3-year RFI | 91.9 | 95% Confidence Interval 90.0 to 93.5 | percentage of participants |
| 3-year DFS-DCIS, OS and RFI Among Analyzed ITT Patients | TAC Arm | 3-year RFI | 94.5 | 95% Confidence Interval 92.8 to 95.9 | percentage of participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TC Arm | 981 | |
| Overall Study | STARTED | TAC Arm | 980 | |
| Overall Study | COMPLETED | TC Arm | 969 | |
| Overall Study | COMPLETED | TAC Arm | 965 | |
| Overall Study | NOT COMPLETED | TC Arm | 12 | |
| Overall Study | NOT COMPLETED | TAC Arm | 15 |
Source ClinicalTrials.gov
Adverse events362
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 | TC Arm | 164 | 969 | 164 |
| other | ANEMIA | Blood and lymphatic system disorders | TAC Arm | 183 | 965 | 183 |
| other | LEUCOPENIA | Blood and lymphatic system disorders | TC Arm | 100 | 969 | 100 |
| other | LEUCOPENIA | Blood and lymphatic system disorders | TAC Arm | 92 | 965 | 92 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | TC Arm | 294 | 969 | 294 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | TAC Arm | 243 | 965 | 243 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | TC Arm | 18 | 969 | 18 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | TAC Arm | 72 | 965 | 72 |
| other | FATIGUE | General disorders | TC Arm | 470 | 969 | 470 |
| other | FATIGUE | General disorders | TAC Arm | 498 | 965 | 498 |
1 to 10 of 362Source ClinicalTrials.gov
See all 362 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TC Arm | 110 | 969 |
| Total, all-cause mortality | TAC Arm | 88 | 965 |
| Total, other adverse events | TC Arm | 680 | 969 |
| Total, other adverse events | TAC Arm | 746 | 965 |
| Total, serious adverse events | TC Arm | 264 | 969 |
| Total, serious adverse events | TAC Arm | 330 | 965 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38335467 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TC Arm vs TAC Arm: deaths from any cause | Trial comparisons |
| TC Arm vs TAC Arm: serious adverse events | 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/NCT00493870
GET https://conductscience.org/api/trials/v1/NCT00493870/results?page=2