Trial · NCT01275677
Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer
NCT01275677, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2020-09-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer. Trials, record NCT01275677. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01275677
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer
- NCT number
- NCT01275677
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,270 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
HER2/Neu Positive, Progesterone Receptor Positive, Recurrent Breast Carcinoma, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7
- Interventions
- Cyclophosphamide, Docetaxel, Doxorubicin, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Paclitaxel, Quality-of-Life Assessment, Trastuzumab
- First posted
- 2011-01-12
- Last updated
- 2025-07-14
- Results first posted
- 2020-09-23
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Alive and Free From Invasive Disease (IDFS) | 5 years | Percentage of patients free from an invasive disease-free survival event where events include any invasive recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause. |
| Secondary | Percentage of Patients Alive and Disease-Free (DFS-DCIS) | 5 years | Percentage of patients free from a disease-free survival event where events include local recurrence (invasive or DCIS), regional or distant recurrence, contralateral breast cancer (invasive or DCIS), second primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause. |
| Secondary | Percentage of Patients Alive and Free From Breast Cancer (BCFS) | 5 years | Percentage of patients free from a breast cancer-free survival event where events include local recurrence (invasive or DCIS), regional or distant recurrence, contralateral breast cancer (invasive or DCIS), or death from any cause. |
| Secondary | Percentage of Patients Alive and Recurrence-Free (RFI) | 5 years | Percentage of patients free from a recurrence-free interval event where events include invasive local, regional, or distant recurrence, or death from breast cancer (censored for death from other causes). |
| Secondary | Percentage of Patients Alive and Free From Distant Recurrence (DRFI) | 5 years | Percentage of patients free from a distant recurrence-free interval event where events include distant recurrence or death from breast cancer (censored for deaths from other causes), regardless of occurrence of any intervening local or regional recurrences, contralateral breast cancers, or non-breast second primary cancer. |
| Secondary | Percentage of Patients Alive (Overall Survival) | 5 years | Percentage of patients alive. |
| Secondary | Toxicity Assessed by Adverse Events | While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. | Percentage of patients who ever experienced grade 2 or higher toxicites. |
| Other | Fcgamma Receptor Polymorphism | From baseline to up to 24 months | The polymorphism of the Fcgamma 158 receptor gene will be dichotomized as V/V (valine) vs. other genotypes and the polymorphism of the Fcgamma 131 receptor gene will be dichotomized as H/H (histidine) vs. other genotypes to evaluate an interaction between treatment group and Fcgamma polymorphism. The Kaplan-Meier method105 will be used to estimate the distribution of the primary endpoints stratified by the dichotomized subgroups, and the log-rank test106 will be used to statistically compare the time-to-event distributions. |
| Other | Change in HER2 mRNA Level | From baseline to 24 months | The interaction between treatment effect and HER2 mRNA level will be evaluated in the proportional hazards model, which would include an indicator for treatment group and the HER2 mRNA level as a continuous variable, and the corresponding interaction term. The log-hazard ratio plot for the interaction term with 95% confidence intervals will be used to determine the cut-off of the HER2 mRNA level that would determine a subset of the patients who would benefit from the adjuvant trastuzumab therapy. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Alive and Free From Invasive Disease (IDFS) | 5 years | Includes all at-risk patients with clinical follow up | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Alive and Disease-Free (DFS-DCIS) | 5 years | Includes all at-risk patients with clinical follow-up | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Alive and Free From Breast Cancer (BCFS) | 5 years | Includes all at-risk patients with clinical follow up | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Alive and Recurrence-Free (RFI) | 5 years | Includes all at-risk patients with clinical follow-up | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Alive and Free From Distant Recurrence (DRFI) | 5 years | Includes all at-risk patients with clinical follow-up | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Alive (Overall Survival) | 5 years | Includes all at-risk patients with follow-up | percentage of patients alive | NUMBER |
| SECONDARY | Toxicity Assessed by Adverse Events | While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. | Includes all at-risk patients with clinical follow-up. | percentage of patients | NUMBER |
| OTHER_PRE_SPECIFIED | Fcgamma Receptor Polymorphism | From baseline to up to 24 months | |||
| OTHER_PRE_SPECIFIED | Change in HER2 mRNA Level | From baseline to 24 months |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Alive and Free From Invasive Disease (IDFS) | Arm I (Chemotherapy) | 89.2 | percentage of patients | ||
| Percentage of Patients Alive and Free From Invasive Disease (IDFS) | Arm II (Chemotherapy, Trastuzumab) | 89.8 | percentage of patients | ||
| Percentage of Patients Alive and Disease-Free (DFS-DCIS) | Arm I (Chemotherapy) | 89.1 | percentage of patients | ||
| Percentage of Patients Alive and Disease-Free (DFS-DCIS) | Arm II (Chemotherapy, Trastuzumab) | 89.6 | percentage of patients | ||
| Percentage of Patients Alive and Free From Breast Cancer (BCFS) | Arm I (Chemotherapy) | 91.0 | percentage of patients | ||
| Percentage of Patients Alive and Free From Breast Cancer (BCFS) | Arm II (Chemotherapy, Trastuzumab) | 90.7 | percentage of patients | ||
| Percentage of Patients Alive and Recurrence-Free (RFI) | Arm I (Chemotherapy) | 92.3 | percentage of patients | ||
| Percentage of Patients Alive and Recurrence-Free (RFI) | Arm II (Chemotherapy, Trastuzumab) | 92.0 | percentage of patients | ||
| Percentage of Patients Alive and Free From Distant Recurrence (DRFI) | Arm I (Chemotherapy) | 93.6 | percentage of patients | ||
| Percentage of Patients Alive and Free From Distant Recurrence (DRFI) | Arm II (Chemotherapy, Trastuzumab) | 92.7 | percentage of patients |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Chemotherapy) | 1,630 | |
| Overall Study | STARTED | Arm II (Chemotherapy, Trastuzumab) | 1,640 | |
| Overall Study | COMPLETED | Arm I (Chemotherapy) | 1,602 | |
| Overall Study | COMPLETED | Arm II (Chemotherapy, Trastuzumab) | 1,598 | |
| Overall Study | NOT COMPLETED | Arm I (Chemotherapy) | 28 | |
| Overall Study | NOT COMPLETED | Arm II (Chemotherapy, Trastuzumab) | 42 |
Source ClinicalTrials.gov
Adverse events164
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 | Alopecia | Skin and subcutaneous tissue disorders | Arm I (Chemotherapy) | 633 | 1,615 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Arm II (Chemotherapy, Trastuzumab) | 653 | 1,625 | |
| other | Anemia | Blood and lymphatic system disorders | Arm I (Chemotherapy) | 222 | 1,615 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Chemotherapy, Trastuzumab) | 327 | 1,625 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Arm I (Chemotherapy) | 161 | 1,615 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Arm II (Chemotherapy, Trastuzumab) | 233 | 1,625 | |
| other | Bone pain | Musculoskeletal and connective tissue disorders | Arm I (Chemotherapy) | 228 | 1,615 | |
| other | Bone pain | Musculoskeletal and connective tissue disorders | Arm II (Chemotherapy, Trastuzumab) | 221 | 1,625 | |
| other | Constipation | Gastrointestinal disorders | Arm I (Chemotherapy) | 135 | 1,615 | |
| other | Constipation | Gastrointestinal disorders | Arm II (Chemotherapy, Trastuzumab) | 124 | 1,625 |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Chemotherapy) | 48 | 1,622 |
| Total, all-cause mortality | Arm II (Chemotherapy, Trastuzumab) | 61 | 1,628 |
| Total, other adverse events | Arm I (Chemotherapy) | 1,362 | 1,615 |
| Total, other adverse events | Arm II (Chemotherapy, Trastuzumab) | 1,418 | 1,625 |
| Total, serious adverse events | Arm I (Chemotherapy) | 31 | 1,615 |
| Total, serious adverse events | Arm II (Chemotherapy, Trastuzumab) | 96 | 1,625 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31821109 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA012027 | NATIONAL SURGICAL ADJUVANT BREAST AND BOWEL PROJECT | WOLMARK, NORMAN | NSABP FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 1985 to 2012 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Chemotherapy) vs Arm II (Chemotherapy, Trastuzumab): deaths from any cause | Trial comparisons |
| Arm I (Chemotherapy) vs Arm II (Chemotherapy, Trastuzumab): 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/NCT01275677
GET https://conductscience.org/api/trials/v1/NCT01275677/events?page=2