Clinical Trial with 4-Hydroxy-17 α-methyl-19-nortestosterone in Advanced Breast Cancer

1964 ◽  
Vol 50 (6) ◽  
pp. 445-456 ◽  
Author(s):  
Sergio Di Pietro ◽  
Bruno Salvatori
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Side Effects ◽  
Antitumor Activity ◽  
Advanced Breast Cancer ◽  
Marked Effect ◽  
Premenopausal Women ◽  
Advanced Breast ◽  
Clinical Feature ◽  
Neoplastic Lesions

Twenty-two women with advanced breast cancer underwent clinical trial with a new hormonal compound, 4-hydroxy-17 α-methyl - 19 - nortestosterone (HMNT), in order to evaluate the antitumor activity of this steroid. The age of the patients ranged from 39 to 72 years; the compound was administrated i.m. at the dose of 50 mg a day, regularly and continuously, as long as a new progression of the neoplastic lesions was observed (in one case the treatment went on over a period of 13 months). An objective regression of the lesions was obtained in 8 of the 22 patients treated. The most impressive clinical feature of this new drug seems to consist in a more marked effect in premenopausal women, under 50 years of age. The compound proved to be practically free of virilizing action and of other unwanted side-effects, at least at the doses employed in this study.

scholarly journals Patient Preferences: Results of a German Adaptive Choice-Based Conjoint Analysis (Market Research Study Sponsored by Eli Lilly and Company) in Patients on Palliative Treatment for Advanced Breast Cancer

Breast Care ◽  
2021 ◽  
pp. 1-9
Author(s):  
Mattea Reinisch ◽  
Norbert Marschner ◽  
Thorsten Otto ◽  
Agnieszka Korfel ◽  
Clemens Stoffregen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Side Effects ◽  
Advanced Breast Cancer ◽  
Patient Preferences ◽  
Advanced Breast ◽  
Line Treatment ◽  
Second Line ◽  
Quantitative Survey ◽  
Therapy Assessment ◽  
Adaptive Choice

<b><i>Introduction:</i></b> Integration of patient preferences into shared decision making improves disease-related outcomes, but such data from patients with advanced breast cancer (aBC) are limited. The objective of this study was to demonstrate the relative importance of overall survival (OS) and progression-free survival (PFS) in relation to quality of life (QoL) and therapy-associated side effects from the perspective of patients with aBC. <b><i>Methods:</i></b> Postmenopausal patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative aBC receiving first- or second-line treatment were recruited throughout Germany. Patient-relevant attributes for aBC therapy assessment were collected using a stepwise multimodal approach. A conjoint matrix was developed, resulting in 2 attributes for therapy goals (OS and PFS), 4 for QoL, and 6 for side effects. An online quantitative survey was then performed using adaptive choice-based conjoint (ACBC) methodology. <b><i>Results:</i></b> The quantitative survey included 104 patients: 67 (64.4%) receiving first-line treatment and 37 (35.6%) receiving second-line treatment. The QoL attribute “physical agility and mobility” received the highest utility score (19.4 of 100%), reflecting the greatest importance to patients, followed by treatment goals (OS [15.2%] and PFS [14.4%]). Therapy-related side effects were less important, with nausea/vomiting being the most important (9.3%), followed by infection (6.4%) and hair loss (5.0%). The McFadden pseudo <i>R</i><sup>2</sup> (0.805), the root likelihood (0.864), and the χ<sup>2</sup> test (2,809.041; <i>p</i> &#x3c; 0.0001) indicated a very good fit of the statistical model. <b><i>Conclusion:</i></b> Using ACBC analysis, it appears that QoL, OS, and PFS are most important to postmenopausal patients with aBC in relation to cancer treatment. Side effects seem to be less important if OS or PFS are prolonged and the QoL is maintained. Thus, QoL, OS, and PFS should be considered equally when making treatment decisions in aBC.

Clinical Trial of Letrozole (femara) versus Aminoglutethimide in Postmenopausal Women with Advanced Breast Cancer

2005 ◽  
Vol 4 (6) ◽  
pp. 338-340
Author(s):  
Xiaoqing LIU ◽  
Santai SONG ◽  
Zefei JIANG ◽  
Weilian LI ◽  
Weixia WANG ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Advanced Breast Cancer ◽  
Postmenopausal Women ◽  
Advanced Breast

scholarly journals Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and Metastatic Breast Cancer Registry

2017 ◽  
Vol 77 (08) ◽  
pp. 870-878 ◽  
Author(s):  
Markus Wallwiener ◽  
Felix Heindl ◽  
Sara Brucker ◽  
Florin-Andrei Taran ◽  
Andreas Hartkopf ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Advanced Breast Cancer ◽  
Cancer Registry ◽  
Data Entry ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Patient Reported ◽  
Trial Staff ◽  
Breast Cancer Registry

Abstract Purpose Patient-reported outcomes (PROs) have been incorporated into clinical trials for many symptoms and medical conditions. A transition from paper-based capture of PROs to electronic PROs (ePROs) has recently started. This study reports on the feasibility of ePRO assessment in a prospective registry including molecular data for patients with advanced breast cancer. Methods As part of the PRAEGNANT network, patients were invited by clinical trial staff, physicians, and nurses to complete three standardized Internet-based questionnaires (EQ 5D 5 L, CES-D and IPAQ). Feasibility was assessed by the staff members who assigned the user accounts by the patients. The completeness of the questionnaires was also assessed. Results Fifteen of 17 patients who were asked agreed to participate to complete the PRO questionnaires (EQ-5D-5L and CES-D). However, the IPAQ (physical activity) questionnaire was only validly completed by 9 patients. Feasibility was ranked better by the physicians and dedicated clinical trial staff than by the nursing staff. Conclusions Incorporating ePRO questionnaires into an advanced breast cancer registry is feasible, and no major hurdles were reported. Involving stakeholders from the start, the application is tailored to the capacities and abilities of both patients and clinical staff. The patientsʼ compliance was better with some questionnaires, but others may present difficulties.

Treatment and Monitoring Patterns Among Premenopausal Women with HR+/HER2− Advanced Breast Cancer

2018 ◽  
Vol 35 (9) ◽  
pp. 1356-1367 ◽  
Author(s):  
Anand A. Dalal ◽  
Geneviève Gauthier ◽  
Patrick Gagnon-Sanschagrin ◽  
Rebecca Burne ◽  
Annie Guérin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Premenopausal Women ◽  
Advanced Breast

A Phase II Clinical Trial of Flutamide in the Treatment of Advanced Breast Cancer

1988 ◽  
Vol 74 (1) ◽  
pp. 53-56 ◽  
Author(s):  
Tiping Zhao ◽  
Guifen He
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Advanced Breast Cancer ◽  
Cancer Patients ◽  
Phase Ii ◽  
Transient Response ◽  
Postmenopausal Breast Cancer ◽  
Phase Ii Clinical Trial ◽  
Advanced Breast ◽  
Breast Cancer Patients

An antiandrogenic agent flutamide was used in the treatment of one male and 14 female postmenopausal breast cancer patients. Only a mild and transient response was seen in 2 female patients. Therefore, flutamide cannot be used solely in the treatment of female postmenopausal breast cancer.

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