Trial · NCT01589367
Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer
NCT01589367, Phase 2, Completed, Seoul National University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer. Trials, record NCT01589367. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01589367
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer
- NCT number
- NCT01589367
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 208 participants, actual
- Lead sponsor
- Seoul National University Hospital
- Conditions
- Hormone Receptor Positive Malignant Neoplasm of Breast
- Interventions
- Metformin, Placebo
- First posted
- 2012-05-01
- Last updated
- 2018-09-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical response rate | 24week(after completing medication, preoperatively) | Comparing with RECIST 1.1 From baseline to 24week(after completing medication, preoperatively) |
| Secondary | Pathologic complete response rate | Postoperation(within 26weeks after starting medication) | In case that under postoperative biopsy, residual breast cancer cell is not present in primary lesion and lymph node. |
| Secondary | Changes of Ki67(%) | Baseline-4week(second core needle biopsy) | IHC is performed for formalin-fixed paraffin embedded tissue at the central laboratory. Ki67 is recorded as % and percentage reduction of baseline and Ki67 expressed cell on day28 are compared. |
| Secondary | Breast conservation rate | Baseline-postoperation(within 26weeks after starting medication) | Before pre-operative anti hormone therapy, the patients are classified into following three types 1. Candidate for BCS 2. Marginal for breast conservation surgery 3. Candidate for mastectomy only 4. Inoperable by standard mastectomy Classification of each type shall be determined by each researcher of each institution subjectively. For future separate objective analysis, central institution will collect image file of mammography of each patient. Type of operation being actually performed in each type is compared. (BCS vs mastectomy) |
| Secondary | Breast density change | Baseline-24week(after completing medication, preoperatively) | Percent mammographic density (%) of cranial-caudal view of opposite breast is measured/compared based on continued variable by using validated computer-assisted thresholding program called Cumulus software (University Toronto, Toronto, Ontario, Canada). |
| Secondary | Toxicity profile of letrozole and metformin | throughout the study | based on NCI-CTCAE version 4.0 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers32
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/NCT01589367
GET https://conductscience.org/api/trials/v1/NCT01589367/papers?page=2