Trial · NCT00256243
Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer
NCT00256243, Phase 2, Completed, Rita Sanghvi, Mehta; results first posted 2014-03-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer. Trials, record NCT00256243. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00256243
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer
- NCT number
- NCT00256243
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Rita Sanghvi, Mehta
- Conditions
- Breast Cancer
- Interventions
- Doxorubicin, Cyclophosphamide, Paclitaxel, Carboplatin, GM-CSF, Trastuzumab
- First posted
- 2005-11-21
- Last updated
- 2018-03-02
- Results first posted
- 2014-03-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Response Rate | 5 years | Clinical response (CR): Normal breast on physical exam. No mass, no thickening, no erythema, no peau d'orange. |
| Secondary | Microscopic Pathological Response Rate | 5 years | pathological response rate: No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Response Rate | 5 years | Of the 48 study participants, one patient refused preoperative but received standard adjuvant AC followed by docetaxel (without trastuzumab), relapsed, and died. Therefore, 47 participants were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Microscopic Pathological Response Rate | 5 years | Of the 48 study participants, one patient refused preoperative but received standard adjuvant AC followed by docetaxel (without trastuzumab), relapsed, and died. Therefore, 47 participants were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Clinical Response Rate | Chemotherapy With GM-CSF | 47 | Participants | ||
| Microscopic Pathological Response Rate | Chemotherapy With GM-CSF | 47 | Participants |
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 | Chemotherapy With GM-CSF | 48 | |
| Overall Study | COMPLETED | Chemotherapy With GM-CSF | 38 | |
| Overall Study | NOT COMPLETED | Chemotherapy With GM-CSF | 10 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy With GM-CSF | 10 | 38 |
| Total, other adverse events | Chemotherapy With GM-CSF | 0 | 38 |
| Total, serious adverse events | Chemotherapy With GM-CSF | 0 | 38 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00256243
GET https://conductscience.org/api/trials/v1/NCT00256243/registered