Trial · NCT01439711
Letrozole in Treating Postmenopausal Women With Ductal Carcinoma in Situ
NCT01439711, Phase 2, Completed, Alliance for Clinical Trials in Oncology; results first posted 2018-03-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Letrozole in Treating Postmenopausal Women With Ductal Carcinoma in Situ. Trials, record NCT01439711. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01439711
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Letrozole in Treating Postmenopausal Women With Ductal Carcinoma in Situ
- NCT number
- NCT01439711
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 108 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Breast Cancer
- Interventions
- letrozole, MRI, conventional surgery
- First posted
- 2011-09-23
- Last updated
- 2018-03-27
- Results first posted
- 2018-03-27
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 3 (V3) | up to 3 months from start of treatment | Mean total MRI FTV change from baseline to month 3 (V3): For patients with more than one measureable lesion on the MRI, the sum over all measureable lesions on the MRI was calculated at each time point. V3 was calculated by subtracting the total MRI FTV measured (i.e. the sum over all lesions present with MRI FTV measurements) at 3 months from the total MRI FTV measured at baseline. For V3 the raw change in the volume will be calculated for each patient and a mean and 95% confidence interval will be constructed using two-sided t-tests. |
| Primary | Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 6 (V6) | up to 6 months from start of treatment | Mean total MRI FTV change from baseline to month 6 (V6): For patients with more than one measureable lesion on the MRI, the sum over all measureable lesions on the MRI was calculated at each time point. V6 was calculated by subtracting the total MRI FTV measured at 6 months from the total MRI FTV measured at baseline. For V6 the raw change in the volume will be calculated for each patient and a mean and 95% confidence interval will be constructed using two-sided t-tests. |
| Secondary | Mean Total MRI Tumor Diameter Change From Baseline to Month 3 | 3-months | To ascertain the change in maximum tumor diameter from baseline to 3 months (D3) the same methods as in Primary outcome #1 will be used but on diameter instead of volume. For patients with more than one lesion longest diameter measurement, the sum of all lesion longest diameter measurements was calculated. |
| Secondary | Change in Maximum Diameter at 6-months Based on Mammographic Measurement (MD6) | 6-months | Change in maximum diameter at 6-months based on mammographic measurement (MD6) will be estimated using the methods in Primary Outcome #1, but using the mammographic measurements instead. |
| Secondary | Type of Primary Surgery (Mastectomy or Lumpectomy) | up to 6 months | Rate of Mastectomy will be estimated as the number of mastectomies divided by the number of surgeries. A 95% confidence interval will be constructed using exact binomial methods. Rate of Lumpectomy will be estimated as the number of lumpectomies divided by the number of surgeries. A 95% confidence interval will be constructed using exact binomial methods. |
| Secondary | Number of Re-excisions Required to Obtain Clear Margins | 3-months and 6-months | |
| Secondary | Extent of Residual DCIS Post Surgery | Up to 6 months post-surgery | |
| Secondary | Presence of Invasive Cancer at Surgery | 3-months and 6-months | |
| Secondary | Size of Margins (Smallest) at Surgery | 3-months and 6-months | |
| Secondary | Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Up to 6 months post surgery | The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event at least possibly related to the study treatment are reported below. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 3 (V3) | up to 3 months from start of treatment | cubic centimeters | MEAN | |
| PRIMARY | Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 6 (V6) | up to 6 months from start of treatment | cubic centimeters | MEAN | |
| SECONDARY | Mean Total MRI Tumor Diameter Change From Baseline to Month 3 | 3-months | millimeters | MEAN | |
| SECONDARY | Change in Maximum Diameter at 6-months Based on Mammographic Measurement (MD6) | 6-months | Patients who completed a mammogram at both time points (baseline and month 6) with measurements available were included in this analysis. | millimeters | MEAN |
| SECONDARY | Type of Primary Surgery (Mastectomy or Lumpectomy) | up to 6 months | Patients who underwent surgery were included in this analysis. | percentage of surgeries | NUMBER |
| SECONDARY | Number of Re-excisions Required to Obtain Clear Margins | 3-months and 6-months | |||
| SECONDARY | Extent of Residual DCIS Post Surgery | Up to 6 months post-surgery | |||
| SECONDARY | Presence of Invasive Cancer at Surgery | 3-months and 6-months | |||
| SECONDARY | Size of Margins (Smallest) at Surgery | 3-months and 6-months | |||
| SECONDARY | Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Up to 6 months post surgery | Patients who had completed the study and had an Adverse Event Form submitted were included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 3 (V3) | Letrozole + MRI | -1.93 | 95% Confidence Interval -2.87 to -0.98 | cubic centimeters | |
| Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 6 (V6) | Letrozole + MRI | -1.82 | 95% Confidence Interval -2.75 to -0.9 | cubic centimeters | |
| Mean Total MRI Tumor Diameter Change From Baseline to Month 3 | Letrozole + MRI | -10.3 | 95% Confidence Interval -13.94 to -6.66 | millimeters | |
| Change in Maximum Diameter at 6-months Based on Mammographic Measurement (MD6) | Letrozole + MRI | -3.31 | 95% Confidence Interval -7.0 to 0.38 | millimeters | |
| Type of Primary Surgery (Mastectomy or Lumpectomy) | Letrozole + MRI | Rate of Mastectomy | 7 | 95% Confidence Interval 2 to 16 | percentage of surgeries |
| Type of Primary Surgery (Mastectomy or Lumpectomy) | Letrozole + MRI | Rate of Lumpectomy | 93 | 95% Confidence Interval 84 to 98 | percentage of surgeries |
| Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Letrozole + MRI | Allergic reaction | 31 | Participants | |
| Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Letrozole + MRI | Cholesterol high | 7 | Participants | |
| Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Letrozole + MRI | Gastrointestinal disorder | 2 | Participants | |
| Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Letrozole + MRI | Hot flashes | 1 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Letrozole + MRI | 108 | |
| Overall Study | COMPLETED | Letrozole + MRI | 68 | |
| Overall Study | NOT COMPLETED | Letrozole + MRI | 40 |
Source ClinicalTrials.gov
Adverse events24
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 | Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Letrozole + MRI | 5 | 90 | 5 |
| other | Nausea | Gastrointestinal disorders | Letrozole + MRI | 3 | 90 | 4 |
| other | Fatigue | General disorders | Letrozole + MRI | 1 | 90 | 2 |
| other | Fever | General disorders | Letrozole + MRI | 1 | 90 | 1 |
| other | Allergic reaction | Immune system disorders | Letrozole + MRI | 3 | 90 | 5 |
| other | Fracture | Injury, poisoning and procedural complications | Letrozole + MRI | 3 | 90 | 3 |
| other | Cholesterol high | Investigations | Letrozole + MRI | 4 | 90 | 6 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Letrozole + MRI | 43 | 90 | 87 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Letrozole + MRI | 1 | 90 | 1 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Letrozole + MRI | 19 | 90 | 28 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Letrozole + MRI | ||
| Total, other adverse events | Letrozole + MRI | 75 | 90 |
| Total, serious adverse events | Letrozole + MRI | 2 | 90 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA037447 | Cancer and Leukemia Group B CCOP Research Base | BERTAGNOLLI, MONICA M; PASKETT, ELECTRA D. | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2015 |
Source NIH RePORTER
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/NCT01439711
GET https://conductscience.org/api/trials/v1/NCT01439711/events?page=2