letrozole and Recrudescence studies

Research Excerpts

Excerpt	Relevance	Reference
"Letrozole is a type 2 aromatase inhibitor that effectively reduces serum estrogen levels."	6.46	Treatment of recurrent endometrial stromal sarcoma with letrozole: a case report and literature review. ( Dunton, CJ; Sylvestre, VT, 2010)
"3 years, there were 165 events involving disease recurrence or the occurrence of contralateral breast cancer (67 with letrozole and 98 with placebo) and 200 deaths (100 in each group)."	5.22	Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years. ( Beck, JT; Gelmon, K; Goss, PE; Gralow, J; Hudis, C; Ingle, JN; Kaur, JS; Muss, H; Parulekar, WR; Pritchard, KI; Robert, NJ; Rubin, S; Stopeck, A; Strasser-Weippl, K; Sturtz, K; Tu, D; Whelan, K; Whelan, T; Winer, E; Wolff, AC, 2016)
"Letrozole was administered at a dose of 2."	2.73	Efficacy of letrozole in the treatment of recurrent platinum- and taxane-resistant high-grade cancer of the ovary or peritoneum. ( Coleman, RL; Deavers, M; Gershenson, DM; Kavanagh, JJ; Levenback, C; Milam, MR; Ramirez, PT; Schmeler, KM; Slomovitz, BM; Smith, JA, 2008)
"Letrozole is a type 2 aromatase inhibitor that effectively reduces serum estrogen levels."	2.46	Treatment of recurrent endometrial stromal sarcoma with letrozole: a case report and literature review. ( Dunton, CJ; Sylvestre, VT, 2010)

Research

Studies (11)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

Change From Baseline in Role Function- Physical Scale on SF(Short Form)-36 Health Survey

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	6 (54.55)	29.6817
2010's	5 (45.45)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
George, A	1
McLachlan, J	1
Tunariu, N	1
Della Pepa, C	1
Migali, C	1
Gore, M	1
Kaye, S	1
Banerjee, S	1
Smith, IE	1
Yeo, B	1
Schiavon, G	1
Goss, PE	2
Ingle, JN	2
Pritchard, KI	2
Robert, NJ	2
Muss, H	1
Gralow, J	1
Gelmon, K	1
Whelan, T	1
Strasser-Weippl, K	1
Rubin, S	1
Sturtz, K	1
Wolff, AC	1
Winer, E	1
Hudis, C	1
Stopeck, A	1
Beck, JT	1
Kaur, JS	1
Whelan, K	1
Tu, D	2
Parulekar, WR	1
Oktay, K	1
Rodriguez-Wallberg, K	1
Schover, L	1
Sasson, IE	1
Taylor, HS	1
Glück, S	1
Sylvestre, VT	1
Dunton, CJ	1
Fatemi, HM	1
Al-Turki, HA	1
Papanikolaou, EG	1
Kosmas, L	1
De Sutter, P	1
Devroey, P	1
Pater, JL	1
Muss, HB	1
Martino, S	1
Piccart, MJ	1
Castiglione, M	1
Shepherd, LE	1
Livingston, RB	1
Davidson, NE	1
Norton, L	1
Perez, EA	1
Abrams, JS	1
Cameron, DA	1
Palmer, MJ	1
Ramirez, PT	1
Schmeler, KM	1
Milam, MR	1
Slomovitz, BM	1
Smith, JA	1
Kavanagh, JJ	1
Deavers, M	1
Levenback, C	1
Coleman, RL	1
Gershenson, DM	1
Brink, S	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Double Blind Randomization to Letrozole or Placebo for Women Previously Diagnosed With Primary Breast Cancer Completing Five Years of Adjuvant Aromatase Inhibitor Either as Initial Therapy or After Tamoxifen (Including Those in The MA.17 Study)[NCT00754845]	Phase 3	1,918 participants (Actual)	Interventional	2004-11-23	Completed
LA LEAST- Luminal A, Limited Endocrine Adjuvant Systemic Therapy. A Trial of Abbreviated Hormone Therapy for Low Risk Hormone Receptor Positive, HER2 Negative Early Breast Cancer[NCT03917082]	Phase 2	290 participants (Anticipated)	Interventional	2019-09-23	Active, not recruiting
A Phase III Randomized Double Blind Study of Letrozole Versus Placebo in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen[NCT00003140]	Phase 3	5,187 participants (Actual)	Interventional	1998-08-24	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Difference between post baseline scores and baseline score of role function-physical scale on SF-36 Health Survey (scale range between 0 and 100 with higher score indicating better quality of life). (NCT00754845)
Timeframe: 8 years

Disease-free Survival (DFS)

Intervention	score on a scale (Least Squares Mean)
Letrozole	-7.74
Placebo	-6.28

It is defined as the months from the day of randomization to the earliest date when a recurrence of the primary disease (recurrence in the breast, chest wall and nodal sites or the development of metastatic disease) or a contralateral breast cancer was observed. Subjects who died without recurrence of the primary disease or the development of the contralateral breast cancer were censored at their death date. If a patient has not recurred, developed a contralateral breast cancer, or died, disease-free survival was censored on the date of the last day the patient was known to be alive. Probability of disease free survival at 5 years is estimated and reported. (NCT00754845)
Timeframe: Unitil the end of study with a median follow up of 75 months

Incidence of Contralateral Breast Cancer

Intervention	probability of DFS at 5 years (Number)
Letrozole	0.95
Placebo	0.91

The annual incidence rate was estimated based on the time to the development of contralateral breast cancer, which was calculated in months from the day of randomization to the diagnosis date of contralateral breast cancer for subjects who had developed the contralateral breast cancer, to the time of death for the patient who died, or to the last day the patient was known alive for subjects without contralateral breast cancer (NCT00754845)
Timeframe: 10 years

Overall Survival (OS)

Intervention	Number of new case per 1000 person years (Number)
Letrozole	2.1
Placebo	4.9

For subjects who died, overall survival was calculated in months from the day of randomization to the date of death. Otherwise, survival was censored at the last day the patient was known to be alive. Probability of overall survival at 5 years is estimated and reported. (NCT00754845)
Timeframe: Until the end of study with a median follow-up of 75 months

Intervention	probability of OS at 5 years (Number)
Arm I	0.93
Arm II	0.94

Article	Year
The optimal duration and selection of adjuvant endocrine therapy for breast cancer: how long is enough? American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting, 2014 Topics: Antineoplastic Agents, Hormonal; Aromatase Inhibitors; Breast Neoplasms; Chemotherapy, Adjuvant; Dru	2014
Exemestane as first-line therapy in postmenopausal women with recurrent or metastatic breast cancer. American journal of clinical oncology, 2010, Volume: 33, Issue:3 Topics: Adenocarcinoma; Aged; Aged, 80 and over; Anastrozole; Androstadienes; Antineoplastic Agents, Hormona	2010
Treatment of recurrent endometrial stromal sarcoma with letrozole: a case report and literature review. Hormones & cancer, 2010, Volume: 1, Issue:2 Topics: Antineoplastic Agents, Hormonal; Aromatase Inhibitors; Endometrial Neoplasms; Female; Humans; Letroz	2010

Article	Year
The role of hormonal therapy in patients with relapsed high-grade ovarian carcinoma: a retrospective series of tamoxifen and letrozole. BMC cancer, 2017, Jun-30, Volume: 17, Issue:1 Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents, Hormonal; Biomarkers, Tumor; Carcinoma; Femal	2017
Preservation of fertility in patients with cancer. The New England journal of medicine, 2009, Jun-18, Volume: 360, Issue:25 Topics: Aromatase Inhibitors; Breast Neoplasms; Chemotherapy, Adjuvant; Female; Fertility; Humans; Letrozole	2009
Aromatase inhibitor for treatment of a recurrent abdominal wall endometrioma in a postmenopausal woman. Fertility and sterility, 2009, Volume: 92, Issue:3 Topics: Abdominal Wall; Aromatase Inhibitors; Endometriosis; Female; Humans; Letrozole; Middle Aged; Nitrile	2009
Successful treatment of an aggressive recurrent post-menopausal endometriosis with an aromatase inhibitor. Reproductive biomedicine online, 2005, Volume: 11, Issue:4 Topics: Aromatase Inhibitors; Colon, Sigmoid; Endometriosis; Female; Humans; Hysterectomy; Letrozole; Middle	2005
New breast cancer drug. U.S. news & world report, 2001, Dec-24, Volume: 131, Issue:26 Topics: Antineoplastic Agents; Aromatase Inhibitors; Breast Neoplasms; Enzyme Inhibitors; Estrogens; Female;	2001

letrozole and Recrudescence