Trial · NCT00408408
Chemotherapy With or Without Bevacizumab in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer That Can Be Removed By Surgery
NCT00408408, Phase 3, Unknown, NSABP Foundation Inc; results first posted 2017-09-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Chemotherapy With or Without Bevacizumab in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer That Can Be Removed By Surgery. Trials, record NCT00408408. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00408408
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy With or Without Bevacizumab in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer That Can Be Removed By Surgery
- NCT number
- NCT00408408
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 1,206 participants, actual
- Lead sponsor
- NSABP Foundation Inc
- Conditions
- Breast Cancer
- Interventions
- bevacizumab, capecitabine, cyclophosphamide, docetaxel, doxorubicin hydrochloride (Adriamycin), gemcitabine hydrochloride
- First posted
- 2006-12-07
- Last updated
- 2017-09-18
- Results first posted
- 2017-09-18
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathologic Complete Response (pCR) of the Primary Tumor in the Breast | Time of surgery, on average 6 or 13 months | Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen. |
| Secondary | pCR in the Breast and Nodes | Time of surgery, on average 6 or 13 months | Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen and axillary lymph nodes. |
| Secondary | Clinical Overall Response (cOR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at the Completion of the Docetaxel-based Portion of Chemotherapy | Assessed at cycle 5 of chemotherapy, on average at 15 weeks | Percentages of patients assessed as Clinical Complete Response or Clinical Partial Response according to RECIST. |
| Secondary | Clinical Overall Response: cOR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens | Three to four weeks after the last chemotherapy dose on average 6 or 13 months | The percentage of patients assessed by physical exam as Clinical Complete Response or Clinical Partial Response according to RECIST. |
| Secondary | Clinical Complete Response (cCR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at Completion of Therapy | Assessed at cycle 5 of chemotherapy, on average at 15 weeks | Percentages of patients assessed as Clinical Complete Response or Clinical Partial Response according to RECIST. |
| Secondary | Clinical Complete Resonse: cCR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens | Three to four weeks after the last chemotherapy dose, on average at 6 or 13 months | The percentage of patients assessed by physical exam as Clinical Complete Response according to RECIST. |
| Secondary | Percentage of Cardiac Events | After each cycle, 3-5 weeks postoperative, 9 and 12 months from study entry, every 6 month years 2-5, and annually years 6-10, for postoperative bevacizumab patients, every 6 weeks during postoperative therapy and at 18 months following study entry. | |
| Secondary | Surgical Complication | 24 months after study entry | Number of patients with Grade 4 or above surgery-related toxicities |
| Secondary | Toxicities Including Events Other Than Congestive Heart Failure, of Chemotherapy Alone, Bevacizumab With Chemotherapy, and Bevacizumab Alone | 24 months after study entry | The number of patients who experienced Grade 1 or above Adverse Events. Referring to the Adverse Events tables for specifics. |
| Secondary | Disease-free Survival (DFS) | Measured through 5 years after study enrollment | Percentage of patients free from local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer after 5 years. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pathologic Complete Response (pCR) of the Primary Tumor in the Breast | Time of surgery, on average 6 or 13 months | percentage of patients | NUMBER | |
| SECONDARY | pCR in the Breast and Nodes | Time of surgery, on average 6 or 13 months | Arm 1A there is no follow up data for 3 patients; Arm 1B no follow up date for 6 patients; Arm 2A no follow up data for 1 patient; Arm 2B no follow up data for 11 patients; Arm 3A no follow up data for 9 patients; and Arm 3B no follow up data for 6 patients | percentage of patients | NUMBER |
| SECONDARY | Clinical Overall Response (cOR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at the Completion of the Docetaxel-based Portion of Chemotherapy | Assessed at cycle 5 of chemotherapy, on average at 15 weeks | For Arm 1A there is no follow up data for 1 patient; Arm 1B no follow up data for 5 patients; Arm 2A no follow up data for 6 patients; Arm 2B no follow up data for 7 patients; Arm 3A no follow up data for 7 patients; Arm 3B no follow up data for 4 patients | percentage of patients | NUMBER |
| SECONDARY | Clinical Overall Response: cOR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens | Three to four weeks after the last chemotherapy dose on average 6 or 13 months | For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2A no follow up data for 5 patients; Arm 2B no follow up data for 8 patients; Arm 3A no follow up data for 5 patients; Arm 3B no follow up data for 4 patients | percentage of patients | NUMBER |
| SECONDARY | Clinical Complete Response (cCR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at Completion of Therapy | Assessed at cycle 5 of chemotherapy, on average at 15 weeks | For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2A no follow up data for 5 patients; Arm 2B no follow up data for 8 patients; Arm 3A no follow up data for 5 patients; Arm 3B no follow up data for 4 patients | percentage of patients | NUMBER |
| SECONDARY | Clinical Complete Resonse: cCR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens | Three to four weeks after the last chemotherapy dose, on average at 6 or 13 months | For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2A no follow up data for 5 patients; Arm 2B no follow up data for 8 patients; Arm 3A no follow up data for 5 patients; Arm 3B no follow up data for 4 patients | percentage of patients | NUMBER |
| SECONDARY | Percentage of Cardiac Events | After each cycle, 3-5 weeks postoperative, 9 and 12 months from study entry, every 6 month years 2-5, and annually years 6-10, for postoperative bevacizumab patients, every 6 weeks during postoperative therapy and at 18 months following study entry. | |||
| SECONDARY | Surgical Complication | 24 months after study entry | For Arm 1A there is no follow up data for 8 patients; Arm 1B no follow up data for 8 patients; Arm 2A no follow up data for 6 patients; Arm 2B no follow up data for 12 patients; Arm 3A no follow up data for 11 patients; Arm 3B no follow up data for 7 patients | participants | NUMBER |
| SECONDARY | Toxicities Including Events Other Than Congestive Heart Failure, of Chemotherapy Alone, Bevacizumab With Chemotherapy, and Bevacizumab Alone | 24 months after study entry | For Arm 1A there is no followup data for 2 patients; for Arm 2A there is no followup data for 1 patient; for Arm 3A there is no followup data for 3 patients; for Arm 1B there is no followup data for 3 patients; for Arm 2B there is no followup data for 5 patients; and for Arm 3B there is no followup data for 2 patients. | participants | NUMBER |
| SECONDARY | Disease-free Survival (DFS) | Measured through 5 years after study enrollment | For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2B no follow up data for 6 patients; Arm 3A no follow up data for 7 patients; Arm 3B no follow up data for 3 patients | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pathologic Complete Response (pCR) of the Primary Tumor in the Breast | Arm 1A: Docetaxel Then AC | 33.7 | 95% Confidence Interval 27.1 to 40.2 | percentage of patients | |
| Pathologic Complete Response (pCR) of the Primary Tumor in the Breast | Arm 1B Docetaxel + Bev Then AC + Bev | 31.6 | 95% Confidence Interval 25.1 to 38.1 | percentage of patients | |
| Pathologic Complete Response (pCR) of the Primary Tumor in the Breast | Arm 2A: Docetaxel + Capecitabine Then AC | 23.5 | 95% Confidence Interval 17.7 to 29.4 | percentage of patients | |
| Pathologic Complete Response (pCR) of the Primary Tumor in the Breast | Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 36.1 | 95% Confidence Interval 29.3 to 42.8 | percentage of patients | |
| Pathologic Complete Response (pCR) of the Primary Tumor in the Breast | Arm 3A: Docetaxel + Gem Then AC | 27.6 | 95% Confidence Interval 21.3 to 33.9 | percentage of patients | |
| Pathologic Complete Response (pCR) of the Primary Tumor in the Breast | Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 35.8 | 95% Confidence Interval 29.2 to 42.4 | percentage of patients | |
| pCR in the Breast and Nodes | Arm 1A: Docetaxel Then AC | 27.3 | 95% Confidence Interval 21.3 to 33.6 | percentage of patients | |
| pCR in the Breast and Nodes | Arm 1B Docetaxel + Bev Then AC + Bev | 24.4 | 95% Confidence Interval 18.6 to 30.6 | percentage of patients | |
| pCR in the Breast and Nodes | Arm 2A: Docetaxel + Capecitabine Then AC | 18.7 | 95% Confidence Interval 13.7 to 24.4 | percentage of patients | |
| pCR in the Breast and Nodes | Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 27.4 | 95% Confidence Interval 21.2 to 33.8 | percentage of patients |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1A: Docetaxel Then AC | 201 | |
| Overall Study | STARTED | Arm 1B Docetaxel + Bev Then AC + Bev | 199 | |
| Overall Study | STARTED | Arm 2A: Docetaxel + Capecitabine Then AC | 204 | |
| Overall Study | STARTED | Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 201 | |
| Overall Study | STARTED | Arm 3A: Docetaxel + Gem Then AC | 197 | |
| Overall Study | STARTED | Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 204 | |
| Overall Study | COMPLETED | Arm 1A: Docetaxel Then AC | 199 | |
| Overall Study | COMPLETED | Arm 1B Docetaxel + Bev Then AC + Bev | 196 | |
| Overall Study | COMPLETED | Arm 2A: Docetaxel + Capecitabine Then AC | 204 | |
| Overall Study | COMPLETED | Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 194 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events420
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 | Alanine aminotransferase increased (ALT/SGPT) | Investigations | Docetaxel Then AC | 2 | 199 | |
| other | Alanine aminotransferase increased (ALT/SGPT) | Investigations | Docetaxel + Bev Then AC + Bev | 9 | 196 | |
| other | Alanine aminotransferase increased (ALT/SGPT) | Investigations | Docetaxel + Capecitabine Then AC | 10 | 203 | |
| other | Alanine aminotransferase increased (ALT/SGPT) | Investigations | Docetaxel + Cape + Bev Then AC + Bev | 7 | 196 | |
| other | Alanine aminotransferase increased (ALT/SGPT) | Investigations | Docetaxel + Gem Then AC | 26 | 194 | |
| other | Alanine aminotransferase increased (ALT/SGPT) | Investigations | Docetaxel + Gem + Bev Then AC + Bev | 35 | 202 | |
| other | Aspartate aminotransferase increased (AST/SGOT) | Investigations | Docetaxel Then AC | 3 | 199 | |
| other | Aspartate aminotransferase increased (AST/SGOT) | Investigations | Docetaxel + Bev Then AC + Bev | 7 | 196 | |
| other | Aspartate aminotransferase increased (AST/SGOT) | Investigations | Docetaxel + Capecitabine Then AC | 5 | 203 | |
| other | Aspartate aminotransferase increased (AST/SGOT) | Investigations | Docetaxel + Cape + Bev Then AC + Bev | 8 | 196 |
1 to 10 of 420Source ClinicalTrials.gov
See all 420 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Docetaxel Then AC | ||
| Total, all-cause mortality | Docetaxel + Bev Then AC + Bev | ||
| Total, all-cause mortality | Docetaxel + Capecitabine Then AC | ||
| Total, all-cause mortality | Docetaxel + Cape + Bev Then AC + Bev | ||
| Total, all-cause mortality | Docetaxel + Gem Then AC | ||
| Total, all-cause mortality | Docetaxel + Gem + Bev Then AC + Bev | ||
| Total, other adverse events | Docetaxel Then AC | 118 | 199 |
| Total, other adverse events | Docetaxel + Bev Then AC + Bev | 150 | 196 |
| Total, other adverse events | Docetaxel + Capecitabine Then AC | 168 | 203 |
| Total, other adverse events | Docetaxel + Cape + Bev Then AC + Bev | 182 | 196 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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 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/NCT00408408
GET https://conductscience.org/api/trials/v1/NCT00408408/results?page=2