Phase II study of the effect of the topical corticosteroid fluocinonide in patients on endocrine therapy for breast cancer or breast cancer prevention with symptoms of vaginal dryness and dyspareunia.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 10105-10105
Author(s):  
Evthokia A. Hobbs ◽  
Kristine Lethert ◽  
Deirdre J. Nauman ◽  
Jenna Bucher ◽  
Emile Latour ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Topical Corticosteroid ◽  
Endocrine Therapy ◽  
Phase Ii ◽  
Index Score ◽  
Low Grade ◽  
Vaginal Symptoms ◽  
Vaginal Dryness ◽  
Number Of Patients ◽  
Patient Reported

10105 Background: Gynecologic symptoms and sexual dysfunction from endocrine therapy are troublesome side effects for a significant number of patients. This study explored amelioration of vaginal dryness and dyspareunia with fluocinonide cream, a strong topical corticosteroid. Methods: A single-arm, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms in women on endocrine therapy in the adjuvant setting for early stage breast cancer was performed. Patients with vaginal symptoms applied topical vaginal fluocinonide 0.05% cream twice a day for two weeks then once daily for two weeks. Patients were assessed for symptoms by weekly completion of the Mayo/North Central Cancer Treatment Group Patient Pretreatment Questionnaire. The primary outcome was a change from baseline in patient-reported effects of vaginal dryness and dyspareunia on a scale from 0 (no symptoms) to 4 (very severe symptoms) from time of enrollment and at 4 weeks. Secondary outcomes were decrease in vaginal itching and total vaginal index score. Comparisons were made with Wilcoxon sign rank test with 2.5% significance level. Results: Thirty-four women were accrued. At 4 weeks compared with baseline, vaginal dryness improved from a median score of 2 (moderate symptoms) to 0 (no symptoms) ( P < .001) and dyspareunia from 3 (severe symptoms) compared with 1 (mild symptoms) ( P = .002). Percentage of patients who had > 2 point improvement in vaginal dryness and dyspareunia was 69.0% and 75% respectively. Secondary analysis showed decrease in vaginal itching score from 1 to 0 ( P = .001) and vaginal index score of 6 to 1 ( P = .002). Twenty-one patients experienced low-grade toxicities which were mostly limited to skin irritation. Conclusions: Fluocinonide 0.05% cream improves vaginal dryness and dyspareunia experienced by women receiving endocrine therapy and has the potential to improve quality of life of cancer survivors and compliance of endocrine therapy. Clinical trial information: NCT00297011.

Phase II study of the multikinase inhibitor dovitinib (TKI258) or placebo in combination with fulvestrant in postmenopausal, endocrine resistant HER2-/HR+ breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS1148-TPS1148
Author(s):  
Fabrice Andre ◽  
Richard Greil ◽  
Neelima Denduluri ◽  
Alejandro Javier Yovine ◽  
Cathy Reddick ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Phase Ii ◽  
Molecular Mechanisms ◽  
Locally Advanced ◽  
Endocrine Resistance ◽  
Metastatic Breast ◽  
Predictive Biomarkers ◽  
Her2 Breast Cancer ◽  
Patient Reported

TPS1148 Background: Overcoming endocrine resistance is a critical goal in the treatment of hormone receptor−positive (HR+) breast cancer. Molecular mechanisms associated with endocrine resistance include adaptive “cross-talk” between the estrogen receptor and the fibroblast growth factor receptor (FGFR). Up to 8% of HR+/HER2- breast cancer patients (pts) have amplification of the FGFR1 gene, which is associated with resistance to endocrine therapy but can be overcome via FGFR1 inhibition in preclinical models. Dovitinib is a potent FGF, VEGF, and PDGF receptor tyrosine kinase inhibitor that demonstrated antitumor activity in heavily pretreated breast cancer pts with FGF pathway amplification (FGFR1, FGFR2, or ligand FGF3; Andre et al, ASCO 2011). Dovitinib may reverse resistance to endocrine therapy related to FGF-pathway amplification and is studied here to determine if it can improve outcomes when combined with fulvestrant. Methods: Postmenopausal HER2-/HR+ locally advanced or metastatic breast cancer pts (N»150) progressing within 12 months of completion of adjuvant endocrine therapy or after ≤ 1 prior endocrine therapy in the advanced setting will be enrolled in this multicenter, randomized, double blind, placebo controlled, phase II trial. Pts will prospectively undergo molecular screening to enrich for FGF-amplification (FGFR1, FGFR2, or FGF3 amplification by qPCR; 45 amplified and 30 non-amplified pts per arm). Pts will be randomized 1:1 to receive fulvestrant (500 mg q4w [with an additional dose 2 wks after the initial dose]) in combination with oral dovitinib (500 mg, 5 days on/2 days off) or placebo until disease progression, unacceptable toxicity, or death. The primary endpoint is progression-free survival, with tumor assessments performed q8w. Secondary endpoints include overall response rate per RECIST v1.1, duration of response, overall survival, ECOG performance status and patient reported outcome scores over time, and safety. The pharmacodynamic effect of dovitinib on FGFR-associated angiogenic pathways in tumor specimens and potential predictive biomarkers of response to dovitinib will be explored.

The effect and safety of Clino-san on vaginal symptoms in breast cancer survivors: A randomized, controlled study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20525-e20525
Author(s):  
J. Kim ◽  
Y. Lee ◽  
N. Park ◽  
Y. Song ◽  
S. Kang
Keyword(s):  
Breast Cancer ◽  
Treatment Group ◽  
Cancer Survivors ◽  
Endocrine Therapy ◽  
Breast Cancer Survivors ◽  
Controlled Study ◽  
Health Index ◽  
Vaginal Symptoms ◽  
Vaginal Dryness ◽  
Vaginal Health

e20525 Background: The purpose of this study was to determine the effect of Clino-san on vaginal symptoms and atrophy in breast cancer survivors treated with chemotherapy or endocrine therapy. Methods: A randomized, double-blind, placebo-controlled study. Breast cancer survivors who experienced menopause after chemotherapy or endocrine therapy were enrolled voluntarily and randomly applied vaginal topical lactic acid, Clino-san or placebo three times per week for 12 weeks. Vaginal dryness and dyspareunia measured by visual analogue scale, vaginal health index, vaginal pH, and the effect on endometrium or ovary were evaluated. Results: Among 89 enrolled women, 81 were evaluated. Forty-two received Clino-san treatment, and the remaining 39 received placebo. Vaginal dryness and dyspareunia in Clino-san treatment group improved compared with placebo group (p=0.012). Clino-san increased vaginal health index, however it is not statistically significant (p=0.058). Vaginal pH decreased more in Clino-san treatment group (p=0.025). There was no significant difference of adverse effects between two groups other than mild irritation at the early time of Clino-san use. Conclusions: Vaginal topical Clino-san could relieve the vaginal symptoms and improve the vaginal health in breast cancer survivors who experienced menopause after cancer treatment. No significant financial relationships to disclose.

Phase II study of adjuvant endocrine therapy with CDK 4/6 inhibitor, ribociclib, for localized ER+/HER2- breast cancer (LEADER).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 531-531
Author(s):  
Laura Spring ◽  
Colleen Griffin ◽  
Steven J. Isakoff ◽  
Beverly Moy ◽  
Seth Andrew Wander ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Endocrine Therapy ◽  
Phase Ii ◽  
Adjuvant Endocrine Therapy ◽  
Adjuvant Setting ◽  
Her2 Breast Cancer ◽  
Number Of Patients ◽  
Grade 3 ◽  
One Year

531 Background: Given the success of CDK 4/6 inhibitors for ER+/HER2- metastatic breast cancer, there is much interest in exploring these agents in early breast cancer to potentially reduce recurrence risk. However, tolerability and adherence are important considerations in the adjuvant setting. We evaluated the tolerability and adherence of adjuvant endocrine therapy with the CDK 4/6 inhibitor, ribociclib, in two different schedules, in a prospective phase II clinical trial. Methods: Eligible patients were those with localized stage I-III ER+ (≥ 10%), HER2- breast cancer who had completed surgery and were on adjuvant endocrine therapy with at least one year or more of treatment remaining. Patients were randomized to receive continuous ribociclib (400 mg daily of 28-day cycle; arm 1) or intermittent ribociclib (600 mg daily on days 1-21 of 28-day cycle; arm 2) for one year, in addition to an aromatase inhibitor (plus GnRH agonist if premenopausal). Toxicities were evaluated using CTCAE version 4.03. Adherence was monitored by review of patient diaries and pill count. Results: Of the 81 patients enrolled, 24 discontinued early. The table shows the current status of the patients based on treatment arm (data cut-off as of 1/31/20; updated results will be presented at meeting). A total of 8 serious adverse events (AEs) have occurred thus far: grade 3 transaminitis (1), grade 4 transaminitis (3), grade 3 colitis (1), grade 3 infection (2), and grade 4 lymphopenia (1). The most common grade 3 or greater AEs leading to study discontinuation thus far were transaminitis (8.6%), neutropenia (2.5%), and fatigue (2.5%). No patients discontinued early due to prolonged QTc. Adherence results will be reported at the meeting. Conclusions: Interim results demonstrate that while serious AEs with one year of adjuvant ribociclib are low, a number of patients discontinued adjuvant CDK 4/6 inhibitor. Tolerability and adherence patterns will need to be carefully considered with CDK 4/6 inhibitors in the adjuvant setting. Clinical trial information: NCT03285412 . [Table: see text]

Are previous episodes of bacterial vaginosis a predictor for vaginal symptoms in breast cancer patients treated with aromatase inhibitors?

2018 ◽  
Vol 24 (2) ◽  
pp. 67-71
Author(s):  
Malene R Gade ◽  
Irina Goukasian ◽  
Nathalie Panduro ◽  
Claus Kamby ◽  
Lisbeth Nilas ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Bacterial Vaginosis ◽  
Aromatase Inhibitor ◽  
Aromatase Inhibitors ◽  
University Hospital ◽  
Breast Cancer Patients ◽  
Vaginal Symptoms ◽  
Vaginal Dryness ◽  
Number Of Patients ◽  
Increased Risk

Objective To estimate the prevalence of vaginal symptoms in postmenopausal women with breast cancer exposed to aromatase inhibitors, and to investigate if the risk of vaginal symptoms is associated with previous episodes of bacterial vaginosis. Methods Patients from Rigshospitalet and Herlev University Hospital, Denmark, were identified through the register of Danish Breast Cancer Cooperation Group and 78 patients participated in the study. Semiquantitave questionnaires and telephone interview were used to assess the prevalence of vaginal symptoms and previous episode(s) of bacterial vaginosis. Multivariable logistic regression models were used to assess the association between vaginal symptoms and previous episodes of bacterial vaginosis. Results Moderate to severe symptoms due to vaginal itching/irritation were experienced by 6.4% (95% CI: 2.8–14.1%), vaginal dryness by 28.4% (95% CI: 19.4–39.5%), and dyspareunia by 23.1% (95% CI: 11.0–42.1%). Patients with earlier episodes of bacterial vaginosis had an increased risk of vaginal dryness when exposed to a treatment with an aromatase inhibitor, adjusted OR 5.5 (95% CI 1.3–21.6). Conclusion A considerable number of patients exposed to aromatase inhibitor have vaginal symptoms and the risk is highest among patients with earlier episodes of bacterial vaginosis.

scholarly journals Neoadjuvant Degarelix Versus Triptorelin in Premenopausal Patients Who Receive Letrozole for Locally Advanced Endocrine-Responsive Breast Cancer: A Randomized Phase II Trial

2019 ◽  
Vol 37 (5) ◽  
pp. 386-395 ◽  
Author(s):  
Silvia Dellapasqua ◽  
Kathryn P. Gray ◽  
Elisabetta Munzone ◽  
Daniela Rubino ◽  
Lorenzo Gianni ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Locally Advanced ◽  
Premenopausal Women ◽  
Rank Test ◽  
Neoadjuvant Endocrine Therapy ◽  
Endocrine Activity ◽  
Patient Reported ◽  
Premenopausal Patients ◽  
To Receive

PURPOSE To evaluate endocrine activity in terms of ovarian function suppression (OFS) of degarelix (a gonadotropin-releasing hormone [GnRH] antagonist) versus triptorelin (a GnRH agonist) in premenopausal patients receiving letrozole as neoadjuvant endocrine therapy for breast cancer. PATIENTS AND METHODS Premenopausal women with stage cT2 to 4b, any N, M0; estrogen receptor and progesterone receptor greater than 50%; human epidermal growth factor receptor 2–negative breast cancer were randomly assigned to triptorelin 3.75 mg administered intramuscularly on day 1 of every cycle or degarelix 240 mg administered subcutaneously (SC) on day 1 of cycle 1 then 80 mg SC on day 1 of cycles 2 through 6, both with letrozole 2.5 mg/day for six 28-day cycles. Surgery was performed 2 to 3 weeks after the last injection. Serum was collected at baseline, after 24 and 72 hours, at 7 and 14 days, and then before injections on cycles 2 through 6. The primary end point was time to optimal OFS (time from the first injection to first assessment of centrally assessed estradiol level ≤ 2.72 pg/mL [≤ 10 pmol/L] during neoadjuvant therapy). The trial had 90% power to detect a difference using a log-rank test with a two-sided α of .05. Secondary end points included response, tolerability, and patient-reported endocrine symptoms. RESULTS Between February 2014 and January 2017, 51 patients were enrolled (n = 26 received triptorelin plus letrozole; n = 25 received degarelix plus letrozole). Time to optimal OFS was three times faster for patients assigned to degarelix and letrozole than to triptorelin and letrozole (median, 3 v 14 days; hazard ratio, 3.05; 95% CI, 1.65 to 5.65; P < .001). Furthermore, OFS was maintained during subsequent cycles for all patients assigned to receive degarelix and letrozole, whereas 15.4% of patients assigned to receive triptorelin and letrozole had suboptimal OFS after cycle 1 (six events during 127 measurements). Adverse events as a result of both degarelix plus letrozole and triptorelin plus letrozole were as expected. CONCLUSION In premenopausal women receiving letrozole for neoadjuvant endocrine therapy, OFS was achieved more quickly and maintained more effectively with degarelix than with triptorelin.

scholarly journals Patient-Reported Cognitive Impairment Among Women With Early Breast Cancer Randomly Assigned to Endocrine Therapy Alone Versus Chemoendocrine Therapy: Results From TAILORx

2020 ◽  
Vol 38 (17) ◽  
pp. 1875-1886 ◽  
Author(s):  
Lynne I. Wagner ◽  
Robert J. Gray ◽  
Joseph A. Sparano ◽  
Timothy J. Whelan ◽  
Sofia F. Garcia ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cognitive Impairment ◽  
Adjuvant Chemotherapy ◽  
Endocrine Therapy ◽  
Early Breast Cancer ◽  
Menopausal Status ◽  
Unique Contribution ◽  
End Point ◽  
Patient Reported ◽  
Chemoendocrine Therapy

PURPOSE Cancer-related cognitive impairment (CRCI) is common during adjuvant chemotherapy and may persist. TAILORx provided a novel opportunity to prospectively assess patient-reported cognitive impairment among women with early breast cancer who were randomly assigned to chemoendocrine therapy (CT+E) versus endocrine therapy alone (E), allowing us to quantify the unique contribution of chemotherapy to CRCI. METHODS Women with a 21-gene recurrence score of 11 to 25 enrolled in TAILORX were randomly assigned to CT+E or E. Cognitive impairment was assessed among a subgroup of 552 evaluable women using the 37-item Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire, administered at baseline, 3, 6, 12, 24, and 36 months. The FACT-Cog included the 20-item Perceived Cognitive Impairment (PCI) scale, our primary end point. Clinically meaningful changes were defined a priori and linear regression was used to model PCI scores on baseline PCI, treatment, and other factors. RESULTS FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months compared with baseline for both groups. The magnitude of PCI change scores was greater for CT+E than E at 3 months, the prespecified primary trial end point, and at 6 months, but not at 12, 24, and 36 months. Tests of an interaction between menopausal status and treatment were nonsignificant. CONCLUSION Adjuvant CT+E is associated with significantly greater CRCI compared with E at 3 and 6 months. These differences abated over time, with no significant differences observed at 12 months and beyond. These findings indicate that chemotherapy produces early, but not sustained, cognitive impairment relative to E, providing reassurance to patients and clinicians in whom adjuvant chemotherapy is indicated to reduce recurrence risk.

scholarly journals PALOMA-3: Phase III Trial of Fulvestrant With or Without Palbociclib in Premenopausal and Postmenopausal Women With Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer That Progressed on Prior Endocrine Therapy—Safety and Efficacy in Asian Patients

2017 ◽  
Vol 3 (4) ◽  
pp. 289-303 ◽  
Author(s):  
Hiroji Iwata ◽  
Seock-Ah Im ◽  
Norikazu Masuda ◽  
Young-Hyuck Im ◽  
Kenichi Inoue ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Endocrine Therapy ◽  
Growth Factor Receptor ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Asian Patients ◽  
Hormone Receptor Positive ◽  
Patient Reported ◽  
Epidermal Growth

Purpose To assess efficacy and safety of palbociclib plus fulvestrant in Asians with endocrine therapy–resistant metastatic breast cancer. Patients and Methods The Palbociclib Ongoing Trials in the Management of Breast Cancer 3 (PALOMA-3) trial, a double-blind phase III study, included 521 patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative metastatic breast cancer with disease progression on endocrine therapy. Patient-reported outcomes (PROs) were assessed on study treatment and at the end of treatment. Results This preplanned subgroup analysis of the PALOMA-3 study included premenopausal and postmenopausal Asians taking palbociclib plus fulvestrant (n = 71) or placebo plus fulvestrant (n = 31). Palbociclib plus fulvestrant improved progression-free survival (PFS) compared with fulvestrant alone. Median PFS was not reached with palbociclib plus fulvestrant (95% CI, 9.2 months to not reached) but was 5.8 months with placebo plus fulvestrant (95% CI, 3.5 to 9.2 months; hazard ratio, 0.485; 95% CI, 0.270 to 0.869; P = .0065). The most common all-cause grade 3 or 4 adverse events in the palbociclib arm were neutropenia (92%) and leukopenia (29%); febrile neutropenia occurred in 4.1% of patients. Within-patient mean trough concentration comparisons across subgroups indicated similar palbociclib exposure between Asians and non-Asians. Global quality of life was maintained; no statistically significant changes from baseline were observed for patient-reported outcome scores with palbociclib plus fulvestrant. Conclusion This is the first report, to our knowledge, showing that palbociclib plus fulvestrant improves PFS in asian patients. Palbociclib plus fulvestrant was well tolerated in this study.

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