Page last updated: 2024-10-30

letrozole and Atypical Ductal Hyperplasia

letrozole has been researched along with Atypical Ductal Hyperplasia in 6 studies

Research Excerpts

ExcerptRelevanceReference
"Primary endocrine therapy for ductal carcinoma in situ (DCIS) as a potential alternative to surgery has been understudied."2.94Phase II Single-Arm Study of Preoperative Letrozole for Estrogen Receptor-Positive Postmenopausal Ductal Carcinoma In Situ: CALGB 40903 (Alliance). ( Bedrosian, I; Caudle, A; Chen, YY; Dickson-Witmer, D; Duong, S; Esserman, L; Guenther, J; Hardman, T; Hendrix, LH; Hieken, T; Hoefer, R; Hudis, CA; Hwang, ES; Hylton, N; Hyslop, T; Krings, G; Lyss, AP; Marks, J; Ollila, DW; Price, E; Winer, E, 2020)
"Estrogens have important roles in ductal carcinoma in situ (DCIS) of the breast."1.39Intratumoral concentration of estrogens and clinicopathological changes in ductal carcinoma in situ following aromatase inhibitor letrozole treatment. ( Amano, G; Amari, M; Ebata, A; Hirakawa, H; Ishida, T; Kakugawa, Y; Miki, Y; Mori, N; Nakamura, Y; Ohuchi, N; Sasano, H; Suzuki, T; Takagi, K; Watanabe, M, 2013)

Research

Studies (6)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's1 (16.67)29.6817
2010's2 (33.33)24.3611
2020's3 (50.00)2.80

Authors

AuthorsStudies
Hwang, ES1
Hyslop, T1
Hendrix, LH1
Duong, S1
Bedrosian, I1
Price, E1
Caudle, A1
Hieken, T1
Guenther, J1
Hudis, CA1
Winer, E1
Lyss, AP1
Dickson-Witmer, D1
Hoefer, R1
Ollila, DW1
Hardman, T1
Marks, J1
Chen, YY1
Krings, G1
Esserman, L1
Hylton, N1
Lazzeroni, M1
DeCensi, A1
Gourd, E1
Blok, EJ1
Kroep, JR1
Meershoek-Klein Kranenbarg, E1
Duijm-de Carpentier, M1
Putter, H1
van den Bosch, J1
Maartense, E1
van Leeuwen-Stok, AE1
Liefers, GJ1
Nortier, JWR1
Rutgers, EJT1
van de Velde, CJH1
Takagi, K1
Ishida, T1
Miki, Y1
Hirakawa, H1
Kakugawa, Y1
Amano, G1
Ebata, A1
Mori, N1
Nakamura, Y1
Watanabe, M1
Amari, M1
Ohuchi, N1
Sasano, H1
Suzuki, T1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Phase II Study of Neoadjuvant Letrozole for Postmenopausal Women With Estrogen Receptor Positive Ductal Carcinoma In SITU (DCIS)[NCT01439711]Phase 2108 participants (Actual)Interventional2012-02-29Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change in Maximum Diameter at 6-months Based on Mammographic Measurement (MD6)

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. (NCT01439711)
Timeframe: 6-months

Interventionmillimeters (Mean)
Letrozole + MRI-3.31

Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 3 (V3)

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. (NCT01439711)
Timeframe: up to 3 months from start of treatment

Interventioncubic centimeters (Mean)
Letrozole + MRI-1.93

Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 6 (V6)

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. (NCT01439711)
Timeframe: up to 6 months from start of treatment

Interventioncubic centimeters (Mean)
Letrozole + MRI-1.82

Mean Total MRI Tumor Diameter Change From Baseline to Month 3

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. (NCT01439711)
Timeframe: 3-months

Interventionmillimeters (Mean)
Letrozole + MRI-10.3

Mean Total MRI Tumor Diameter Change From Baseline to Month 6

Mean total MRI tumor diameter change from baseline to month 6: To ascertain the change in maximum tumor diameter from baseline to 6 months (D6) the same methods as in Primary Outcome #2 will be used but on diameter instead of volume. (NCT01439711)
Timeframe: 6 months

Interventionmillimeters (Mean)
Letrozole + MRI-16.66

Mean Total MRI Tumor Diameter Change From Baseline to Month 6

To ascertain the change in maximum tumor diameter from baseline to 6 months (D6) the same methods as in Primary outcome #2 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. (NCT01439711)
Timeframe: 6 months

Interventionmillimeters (Mean)
Letrozole + MRI-16.66

Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

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. (NCT01439711)
Timeframe: Up to 6 months post surgery

InterventionParticipants (Count of Participants)
Allergic reactionCholesterol highGastrointestinal disorderHot flashes
Letrozole + MRI31721

Type of Primary Surgery (Mastectomy or Lumpectomy)

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. (NCT01439711)
Timeframe: up to 6 months

Interventionpercentage of surgeries (Number)
Rate of MastectomyRate of Lumpectomy
Letrozole + MRI793

Trials

2 trials available for letrozole and Atypical Ductal Hyperplasia

ArticleYear
Phase II Single-Arm Study of Preoperative Letrozole for Estrogen Receptor-Positive Postmenopausal Ductal Carcinoma In Situ: CALGB 40903 (Alliance).
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020, 04-20, Volume: 38, Issue:12

    Topics: Antineoplastic Agents; Biomarkers, Tumor; Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating;

2020
Optimal Duration of Extended Adjuvant Endocrine Therapy for Early Breast Cancer; Results of the IDEAL Trial (BOOG 2006-05).
    Journal of the National Cancer Institute, 2018, 01-01, Volume: 110, Issue:1

    Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Aromatase Inhibitors; Breast Neoplasms; Carcin

2018

Other Studies

4 other studies available for letrozole and Atypical Ductal Hyperplasia

ArticleYear
De-Escalating Treatment of Low-Risk Breast Ductal Carcinoma In Situ.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020, 04-20, Volume: 38, Issue:12

    Topics: Breast Neoplasms; Carcinoma, Ductal, Breast; Carcinoma, Intraductal, Noninfiltrating; Humans; Letroz

2020
Preoperative endocrine therapy for ductal carcinoma in situ.
    The Lancet. Oncology, 2020, Volume: 21, Issue:4

    Topics: Carcinoma, Intraductal, Noninfiltrating; Estrogens; Humans; Letrozole; Mastectomy, Segmental; Postme

2020
Intratumoral concentration of estrogens and clinicopathological changes in ductal carcinoma in situ following aromatase inhibitor letrozole treatment.
    British journal of cancer, 2013, Jul-09, Volume: 109, Issue:1

    Topics: Aged; Aromatase; Aromatase Inhibitors; Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating; Es

2013
NCCN Guideline update: Breast Cancer Version 1.2004.
    Journal of the National Comprehensive Cancer Network : JNCCN, 2004, Volume: 2, Issue:3

    Topics: Anastrozole; Antineoplastic Agents, Hormonal; Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrat

2004