Trial · NCT00941330

Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers

NCT00941330, Phase 2, Completed, Emory University; results first posted 2017-04-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers. Trials, record NCT00941330. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00941330

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers
NCT number: NCT00941330
Status: Completed
Phases: Phase 2
Enrollment: 31 participants, actual
Lead sponsor: Emory University
Conditions: Breast Cancer
Interventions: Exemestane, Docetaxel, Cytoxan
First posted: 2009-07-17
Last updated: 2017-04-10
Results first posted: 2017-04-10

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pathologic Complete Response	At time of definitive surgery	Patients must have measurable disease by clinical examination. Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR but may be recorded separately. If pathologic stage was the same as clinical stage, it was called stable; if it was higher, upstaged (worse outcome); if lower, downstaged (better outcome). Pathologic stage was determined by Emory board-certified pathologists.
Secondary	Response Rate by Imaging	Every 2 months up to 3 years	Arm A and recurrence score ≤10: Patients will have radiologic assessment of response to exemestane by clinical examination every 4 weeks and by radiologic assessment every 2 months. Once maximal response has been achieved (stable disease for 2 months after at least 4 months of treatment by radiologic assessment) or when 12 months of therapy has been given patients will proceed to surgery. Arm B: Patients will be assessed for surgery after 6 cycles of docetaxel and cytoxan (TC) (18 weeks). On arm A and recurrence score ≤10 patients will be reassessed for surgery once maximal radiologic response is achieved. On arm B, patients will be reassessed for surgery after 6 cycles of TC (18 weeks). Radiographic images were analyzed by a breast radiologist who looked at preoperative and postoperative breast mass imaging. If mass was smaller/less extensive, it was considered improved.

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	Pathologic Complete Response	At time of definitive surgery	One patient in Arm B did not have surgery.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Response Rate by Imaging	Every 2 months up to 3 years	Data were not available for 5 patients (4 withdrew and 1 did not have surgery).	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Pathologic Complete Response	A: Exemestane	Downstaged	5	Participants
Pathologic Complete Response	B: Docetaxel and Cytoxan	Downstaged	1	Participants
Pathologic Complete Response	A: Exemestane	Stable	4	Participants
Pathologic Complete Response	B: Docetaxel and Cytoxan	Stable	2	Participants
Pathologic Complete Response	A: Exemestane	Upstaged	5	Participants
Pathologic Complete Response	B: Docetaxel and Cytoxan	Upstaged	5	Participants
Response Rate by Imaging	A: Exemestane	Improved	9	Participants
Response Rate by Imaging	B: Docetaxel and Cytoxan	Improved	2	Participants
Response Rate by Imaging	A: Exemestane	Stable	6	Participants
Response Rate by Imaging	B: Docetaxel and Cytoxan	Stable	4	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	A: Exemestane	15
Overall Study	STARTED	B: Docetaxel and Cytoxan	11
Overall Study	COMPLETED	A: Exemestane	14
Overall Study	COMPLETED	B: Docetaxel and Cytoxan	9
Overall Study	NOT COMPLETED	A: Exemestane	1
Overall Study	NOT COMPLETED	B: Docetaxel and Cytoxan	2

Source ClinicalTrials.gov

Adverse events96

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
other	Fever	General disorders	A: Exemestane	1	15
other	Fever	General disorders	B: Docetaxel and Cytoxan	1	11
other	Elevated Liver Enzymes	Hepatobiliary disorders	A: Exemestane	0	15
other	Elevated Liver Enzymes	Hepatobiliary disorders	B: Docetaxel and Cytoxan	1	11
other	Lower Extremity Edema	General disorders	A: Exemestane	1	15
other	Lower Extremity Edema	General disorders	B: Docetaxel and Cytoxan	2	11
other	Fatigue	General disorders	A: Exemestane	7	15
other	Fatigue	General disorders	B: Docetaxel and Cytoxan	9	11
other	Rhinitis	Respiratory, thoracic and mediastinal disorders	A: Exemestane	2	15
other	Rhinitis	Respiratory, thoracic and mediastinal disorders	B: Docetaxel and Cytoxan	1	11

1 to 10 of 96Source ClinicalTrials.gov

See all 96 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	A: Exemestane
Total, all-cause mortality	B: Docetaxel and Cytoxan
Total, other adverse events	A: Exemestane	13	15
Total, other adverse events	B: Docetaxel and Cytoxan	10	11
Total, serious adverse events	A: Exemestane	0	15
Total, serious adverse events	B: Docetaxel and Cytoxan	1	11

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
A: Exemestane vs B: Docetaxel and Cytoxan: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00941330

GET https://conductscience.org/api/trials/v1/NCT00941330/events?page=2

API reference For AI assistants