Results of a phase Ib study of Q-122 treatment of vasomotor symptoms in breast cancer patients.

2015 ◽  
Vol 33 (28_suppl) ◽  
pp. 99-99 ◽  
Author(s):  
Wendy Painter ◽  
April L. Speed ◽  
Kiwita Phillips ◽  
Priscilla Pemu ◽  
Alice Robertson ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Phase 1 ◽  
Hot Flashes ◽  
Menopausal Symptoms ◽  
Vasomotor Symptoms ◽  
Breast Cancer Patients ◽  
Open Label ◽  
Dose Escalation Study ◽  
Drug Free

99 Background: Breast cancer patients taking tamoxifen (TAM) or an aromatase inhibitor (AI) often develop severe vasomotor symptoms (VMS) yet the only FDA approved non-hormonal treatment for VMS, 7.5 mg paroxetine, has a warning against concomitant use with TAM. Q-122, an orally-available small molecule, is being developed to address this unmet medical need. Results from the Phase 1b study, Q-1001, are presented. Methods: Q-1001 was a Phase 1 open-label, two-dose, dose-escalation study of the safety and preliminary effectiveness of Q-122 in females with breast cancer currently taking TAM or an AI and experiencing an average of at least 7-8 moderate to severe hot flashes per day. Key exclusion criteria included significant renal or hepatic disease, untreated hyperthyroidism and clinically significant abnormal laboratory findings. The study period included a 2 week drug-free screening phase, 28 day treatment phase, and 2 week drug-free follow-up period. Subjects were initially enrolled into Group 1 (100 mg Q-122) followed by Group 2 (200 mg Q-122). Safety was assessed by review of adverse events (AEs), physical findings and laboratory values. The primary efficacy endpoints were mean changes in frequency and severity (hot flash severity score, HFSS) of moderate and severe hot flashes from baseline to Week 4. Menopausal symptoms were assessed using the Greene Climacteric Scale (GCS). Results: 10 and 11 subjects received 100 and 200 mg Q-122 respectively; 8 subjects in each group completed the study. At the end of treatment for groups 1 and 2 respectively, the daily average frequency of hot flashes was reduced from 9.9 to 4.1 and from 8.6 to 3.2, and the mean HFSS was reduced by 62% and 68% from baseline values. Menopausal symptoms assessed using the GCS were significantly reduced from baseline (psychological: -82%; somatic: -65%; vasomotor: -65%). All AEs (n = 29) were either mild (79%) or moderate (21%) in severity and only 3 (all in one subject) were considered possibly related to study drug. Conclusions: Treatment with Q-122 resulted in significant reduction in the frequency and severity of VMS and improvement in menopausal symptoms as assessed by the GCS. No safety issues associated with the use of Q-122 were identified in this study.

Radioprotection study of topical norepinephrine in postsurgical breast cancer patients.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS9152-TPS9152
Author(s):  
James F. Cleary ◽  
George M. Cannon ◽  
Jens C. Eickhoff ◽  
Allen L Thunberg ◽  
William E Fahl
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Ductal Carcinoma ◽  
Phase 1 ◽  
Lobular Carcinoma ◽  
Free Radical Scavengers ◽  
Breast Cancer Patients ◽  
Clinical Trial Registry ◽  
Open Label ◽  
Treatment Site

TPS9152 Background: This study derives from radiodermatitis studies in a rat model evaluating radioprotection from topical norepinephrine application. In the model, increasing radiation doses induce dermatitis of increasing severity, ranging from mild erythema to wet desquamation. The model was initially designed to identify topical radioprotectants that function as oxygen free radical scavengers. In an experiment designed to test the hypothesis that the co-application of a topical vasoconstrictor and an aminothiol scavenger would limit the systemic uptake of the scavenger, it was observed that the combination was synergistic and that the topical vasoconstrictor was active when administered alone as a control. Subsequent experiments demonstrated that topical a-adrenergic receptor agonists are active in preventing radiodermatitis. The data are consistent with a mechanism based on local and transient vasoconstriction within the skin, which reduces local tissue oxygenation. This subsequently limits the formation of radiation-induced reactive oxygen species and protects skin stem cells from radiation damage. Methods: Two Phase 1 safety studies have been conducted, one in normal volunteers and one in cancer patients receiving palliative radiation therapy for bone metastases. This study is a nonrandomized, open-label safety and exploratory study in post-surgical breast cancer patients treated with 45 to 50 Gy to the whole breast and axilla. A 10-16 Gy boost to the lumpectomy region is permitted. Eligible patients are age 18 years or older with a diagnosis of Stage Ia (T1, N0, M0), Stage Ib (T0 or 1, N1mic, M0) or Stage IIa (T<3cm, N0, M0) infiltrating ductal or lobular carcinoma of the breast or ductal carcinoma in situ (DCIS). The dose is a single daily topical application of 3.0 mL of norepinephrine HCl (82.3 mg/mL in 70% ethanol) applied to the same 50 cm2 treatment site in the axilla about 20 minutes prior to each radiotherapy fraction. The radiodermatitis severity at the treatment site will be compared to surrounding (untreated) control areas. 5 of planned 12 patients have been enrolled. Clinical trial registry number NCT01263366.

Single agent activity of U3-1402, a HER3-targeting antibody-drug conjugate, in breast cancer patients: Phase 1 dose escalation study.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. 2512-2512 ◽  
Author(s):  
Takahiro Kogawa ◽  
Kan Yonemori ◽  
Norikazu Masuda ◽  
Shunji Takahashi ◽  
Masato Takahashi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Dose Escalation ◽  
Phase 1 ◽  
Single Agent ◽  
Breast Cancer Patients ◽  
Antibody Drug Conjugate ◽  
Dose Escalation Study ◽  
Drug Conjugate ◽  
Antibody Drug

Phase III Randomized Placebo-Controlled Trial of Two Doses of Megestrol Acetate as Treatment for Menopausal Symptoms in Women With Breast Cancer: Southwest Oncology Group Study 9626

2008 ◽  
Vol 26 (10) ◽  
pp. 1650-1656 ◽  
Author(s):  
J. Wendall Goodwin ◽  
Stephanie J. Green ◽  
Carol M. Moinpour ◽  
James D. Bearden ◽  
Jeffrey K. Giguere ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Controlled Trial ◽  
Hot Flashes ◽  
Study Drug ◽  
Menopausal Symptoms ◽  
Phase Iii ◽  
Vasomotor Symptoms ◽  
Open Label ◽  
Blinded Study ◽  
Southwest Oncology Group Study

Purpose Prior progestin studies treating hot flashes in women have been short duration and single dose. This study tests the progestin megesterol acetate (MA) at two doses versus placebo over 6 months. Patients and Methods Patients with T1-3, N0-1, M0 breast cancer were eligible after completion of surgery and chemotherapy and at least 4 months of tamoxifen (if prescribed). Women were required to have at least 10 hot flashes of any severity or at least five severe episodes per week. Patients were randomly assigned to placebo, MA 20 mg, or MA 40 mg for 3 months. Success at 3 months was defined as completion of treatment with a ≥ 75% reduction in hot flashes from baseline. If success was achieved, drug treatment for another 3 months was given on the same blinded arm; if not, open-label MA 20 mg was added to blinded study drug and continued for 3 months. Other menopausal symptoms were also assessed. Results Two hundred eighty eight eligible women were randomly assigned (286 eligible), of whom 85% were on tamoxifen, 40% had over 63 hot flashes/week, and 75% had vasomotor symptoms for ≥ 6 months. Success at 3 months was 14% on placebo, 65% on 20 mg, and 48% on 40 mg (both MA doses superior to placebo; P < .0001). Most successes at 3 months were maintained at 6 months (77% on 20 mg and 81% on 40 mg). Conclusion MA significantly reduced vasomotor symptoms with durable benefit over 6 months. MA 20 mg/d is the preferred dose. There was no significant impact on other menopausal symptoms.

Management of Early Menopause/Premature Ovarian Insufficiency in Women with or at High Risk of Breast Cancer

2021 ◽  
Author(s):  
Annabelle Brennan ◽  
Martha Hickey
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Survival Rates ◽  
Well Being ◽  
Menopausal Symptoms ◽  
Vasomotor Symptoms ◽  
Hot Flushes ◽  
Breast Cancer Patients ◽  
Night Sweats ◽  
Breast Malignancies

AbstractThe global incidence of breast cancer is increasing, as is the efficacy of treatments. Consequently, increasing survival rates reinforce the importance of survivorship issues, including posttreatment menopausal symptoms, sexual function, and mental health and well-being. Breast cancer patients can experience a range of menopausal symptoms associated with their treatment. Most commonly women may experience vasomotor symptoms, including hot flushes and night sweats. Particularly for women on maintenance tamoxifen therapy, up to 80% will experience hot flushes, with almost one-third of these women reporting severe symptoms. Breast cancer patients may also experience genitourinary symptoms of menopause, which may include vaginal dryness and irritation, dyspareunia, and dysuria. Hormonal therapy has long been established as the most effective treatment for vasomotor symptoms. However, the hormonal nature of breast malignancies renders systemic hormone therapies unsuitable for these patients, posing a unique treatment challenge, which may result in clinicians not feeling confident to manage them. Consequently, this review outlines pharmacological and nonpharmacological options for women with bothersome menopausal symptoms after breast cancer treatment and provides practical, evidence-based guidance for clinicians.

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