Trial · NCT01368263

Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer

NCT01368263, Phase 2, Terminated, Washington University School of Medicine; results first posted 2015-02-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer. Trials, record NCT01368263. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01368263

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Trial

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

Title: Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer
NCT number: NCT01368263
Status: Terminated
Phases: Phase 2
Enrollment: 8 participants, actual
Lead sponsor: Washington University School of Medicine
Conditions: Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
Interventions: goserelin acetate, letrozole, anastrozole, chemotherapy, Surgery
First posted: 2011-06-07
Last updated: 2015-04-03
Results first posted: 2015-02-20

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Pathologic Complete Response (CR) Rate	1 month	* In patients with Ki67 \>10% and \<= 15 pg/ml at 4 weeks. * The pCR rate for neo-adjuvant chemotherapy is defined as 100 times the number of eligible patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary or sentinel lymph nodes divided by the total number of eligible patients who received neo-adjuvant chemotherapy.
Primary	Acceptability of Management With Surgical Oophorectomy/Continued LHRH With Continued Oral Endocrine Therapy and no Chemotherapy	6 months post neoadjuvant endocrine therapy and surgery	Proportion of patients with a PEPI score of 0 and pathological stage 1 who choose to forego chemotherapy.
Secondary	Relationship Between Pretreatment FFNP-PET Standard Uptake Value (SUV) and 4-week Post-treatment Ki-67	Baseline and 4 weeks post-treatment
Secondary	Preoperative Endocrine Prognostic Index Score (PEPI Score)	At time of definitive surgery	To obtain the PEPI score, risk points for relapse-free survival (RFS) and breast cancer-specific survival (BCSS) are assigned depending on the hazard ratio (HR) from the multivariable analysis. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and estrogen receptor status of the surgical specimen. A HR in the range of 1 to 2 receives one risk point; a HR in the 2 to 2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each patient is the sum of all the risk points accumulated from the four factors in the model, ranges from 0 (best possible outcome) to 12 (worst possible outcome).
Secondary	PEPI-0 Rate in Patients Whose Estradiol is Fully Suppressed (< or = 15 pg/mL) and Tumor Ki67 Level is 10% or Less	16 weeks

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pathologic Complete Response (CR) Rate	1 month	There were no evaluable participants to analyze in Group 1, 2, or 3. No participants met the criteria for Ki67 \>10% and estradiol levels of \<= 15 pg/ml at 4 weeks.
PRIMARY	Acceptability of Management With Surgical Oophorectomy/Continued LHRH With Continued Oral Endocrine Therapy and no Chemotherapy	6 months post neoadjuvant endocrine therapy and surgery	None of the participants had a PEPI score and 0 and pathological stage 1.
SECONDARY	Relationship Between Pretreatment FFNP-PET Standard Uptake Value (SUV) and 4-week Post-treatment Ki-67	Baseline and 4 weeks post-treatment	This outcome was not analyzed due to funding issues.
SECONDARY	Preoperative Endocrine Prognostic Index Score (PEPI Score)	At time of definitive surgery	2 participants in Group 1 did not have a PEPI score at time of surgery as (1) participant did not have nodal dissection and (1) did not have surgery. Both participants in Group 2 and Group 3 did not have surgery study tissue collected	participants	NUMBER
SECONDARY	PEPI-0 Rate in Patients Whose Estradiol is Fully Suppressed (< or = 15 pg/mL) and Tumor Ki67 Level is 10% or Less	16 weeks	(1) of the participants in Group 1 had an inconclusive PEPI score at week 16 and was not evaluable. (1) of the participants in Group 1 did not have surgery and was not evaluable. Participants in Group 2 and Group 3 were not evaluable for this outcome as the estradiol and Ki67 levels were above outcome specified levels.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group5

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

Outcome	Group	Category	Value	Units
Preoperative Endocrine Prognostic Index Score (PEPI Score)	Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	PEPI Score 1	1	participants
Preoperative Endocrine Prognostic Index Score (PEPI Score)	Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	PEPI Score 4	1	participants
Preoperative Endocrine Prognostic Index Score (PEPI Score)	Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	PEPI Score 7	1	participants
Preoperative Endocrine Prognostic Index Score (PEPI Score)	Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	PEPI Score 8	1	participants
PEPI-0 Rate in Patients Whose Estradiol is Fully Suppressed (< or = 15 pg/mL) and Tumor Ki67 Level is 10% or Less	Group 1 (Ki67 <10%, E2 <= 15 pg/ml)		0	percentage of participants

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	6
Overall Study	STARTED	Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)	1
Overall Study	STARTED	Group 3 (E2 > 15 pg/ml)	1
Overall Study	COMPLETED	Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	6
Overall Study	COMPLETED	Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)	1
Overall Study	COMPLETED	Group 3 (E2 > 15 pg/ml)	1
Overall Study	NOT COMPLETED	Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	0
Overall Study	NOT COMPLETED	Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)	0
Overall Study	NOT COMPLETED	Group 3 (E2 > 15 pg/ml)	0

Source ClinicalTrials.gov

Adverse events90

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	Fatigue	General disorders	Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	6	6
other	Fatigue	General disorders	Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)	0	1
other	Fatigue	General disorders	Group 3 (E2 > 15 pg/ml)	0	1
other	Chills	General disorders	Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	3	6
other	Chills	General disorders	Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)	0	1
other	Chills	General disorders	Group 3 (E2 > 15 pg/ml)	0	1
other	Right heel pain	Musculoskeletal and connective tissue disorders	Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	1	6
other	Right heel pain	Musculoskeletal and connective tissue disorders	Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)	0	1
other	Right heel pain	Musculoskeletal and connective tissue disorders	Group 3 (E2 > 15 pg/ml)	0	1
other	Hot flashes	Endocrine disorders	Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	6	6

1 to 10 of 90Source ClinicalTrials.gov

See all 90 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Group 1 (Ki67 <10%, E2 <= 15 pg/ml)
Total, all-cause mortality	Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)
Total, all-cause mortality	Group 3 (E2 > 15 pg/ml)
Total, other adverse events	Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	6	6
Total, other adverse events	Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)	1	1
Total, other adverse events	Group 3 (E2 > 15 pg/ml)	1	1
Total, serious adverse events	Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	0	6
Total, serious adverse events	Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)	0	1
Total, serious adverse events	Group 3 (E2 > 15 pg/ml)	0	1

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.

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/NCT01368263

GET https://conductscience.org/api/trials/v1/NCT01368263/events?page=2

API reference For AI assistants