MedPath

Tamoxifen

Generic Name
Tamoxifen
Brand Names
Soltamox
Drug Type
Small Molecule
Chemical Formula
C26H29NO
CAS Number
10540-29-1
Unique Ingredient Identifier
094ZI81Y45
Background

Tamoxifen is a non-steroidal antiestrogen used to treat estrogen receptor positive breast cancers as well as prevent the incidence of breast cancer in high risk populations. Tamoxifen is used alone or as an adjuvant in these treatments. Tamoxifen may no longer be the preferred treatment for these types of cancers as patients generally have better survival, side effect profiles, and compliance with anastrozole.

Tamoxifen was granted FDA approval on 30 December 1977.

Indication

Tamoxifen is indicated to treat estrogen receptor positive metastatic breast cancer in adults, as an adjuvant in the treatment of early stage estrogen receptor positive breast cancer in adults, to reduce the risk of invasive breast cancer after surgery and radiation in adult women with ductal carcinoma in situ.

Associated Conditions
Breast Cancer, Contralateral Breast Cancer, Desmoid Tumor, Early Stage Estrogen Receptor (ER) Positive Breast Cancer, Gynecomastia, Invasive Breast Cancer, Ovarian Cancer, Puberty, Precocious, Metastatic Estrogen Receptor Positive Breast Cancer
Associated Therapies
Ovulation induction therapy

Denosumab Shows Promise as Immune Modulator in Breast Cancer Treatment

• The D-BIOMARK clinical trial reveals that denosumab, commonly used for osteoporosis and bone complications, enhances immune cell infiltration in breast cancer tumors despite showing no direct anti-proliferative effects. • The drug's immune-boosting properties were most pronounced in luminal B breast cancer, a subtype that typically responds poorly to current immunotherapies, potentially opening new treatment avenues. • Researchers from ICO, IDIBELL, and CNIO collaborated on this study, demonstrating how denosumab inhibits the RANK pathway, which plays a key role in breast cancer development and progression.

ARX788 Demonstrates Significant PFS Benefit in HER2-Positive Breast Cancer

• A phase III trial of ARX788 showed a significantly longer median progression-free survival (PFS) of 11.3 months compared to 8.2 months with lapatinib plus capecitabine (LC) in HER2-positive advanced breast cancer patients. • The objective response rate (ORR) was higher in the ARX788 group (63.8%) compared to the LC group (52.7%), with a significantly longer duration of response (DoR) of 12.5 months versus 8.3 months. • ARX788 demonstrated a manageable safety profile, with the most frequent treatment-related adverse events (TRAEs) including hepatic enzyme increase, dry eye, blurred vision, alopecia, and interstitial lung disease (ILD). • The study suggests ARX788 could be an alternative second-line treatment option for HER2-positive advanced breast cancer patients who have progressed on trastuzumab and taxane.

Pfizer's Sasanlimab Plus BCG Shows Promise in BCG-Naive, High-Risk NMIBC

• Pfizer's Phase 3 CREST trial showed that sasanlimab combined with BCG significantly improved event-free survival in BCG-naive, high-risk NMIBC patients. • The combination therapy demonstrated a clinically meaningful and statistically significant improvement compared to BCG alone in the study. • Sasanlimab's safety profile in combination with BCG was consistent with the known profiles of both agents, according to the trial data. • Pfizer plans to submit the CREST trial results for presentation at an upcoming medical congress and discuss potential regulatory filings.

Advancements in Breast Cancer Research Unveiled at SABCS 2024

• The PATINA trial suggests palbociclib with anti-HER2 and endocrine therapy may become a new standard for HR+, HER2+ metastatic breast cancer. • COMET trial indicates active monitoring is comparable to surgery for low-risk DCIS, offering a potential alternative management option. • OlympiA trial's long-term results reinforce olaparib's role in preventing recurrence and highlight the importance of BRCA testing for early-stage breast cancer.

SABCS 2024: Key Advances in Breast Cancer Treatment Highlighted

• Patritumab deruxtecan shows sustained responses with fewer toxicities compared to chemotherapy in neoadjuvant treatment for early breast cancer. • Olaparib demonstrates long-term efficacy in patients with HER2-negative, high-risk breast cancer harboring BRCA1/2 mutations, improving invasive and distant disease-free survival. • Fam-trastuzumab deruxtecan-nxki (T-DXd) improves progression-free survival compared to physician's choice of therapy in HR-positive, HER2-low metastatic breast cancer. • Immediate surgery reduces local recurrence in elderly breast cancer patients, while active monitoring proves non-inferior to standard treatment in low-risk DCIS.

EUROPA Trial: Radiotherapy Preserves Quality of Life Better Than Endocrine Therapy in Older Breast Cancer Patients

• Interim analysis of the EUROPA trial reveals that radiotherapy is associated with better health-related quality of life (HRQOL) compared to endocrine therapy in older women with low-risk early breast cancer. • The study, involving 731 women aged 70 and older, assessed HRQOL using the EORTC QOL Questionnaire-30, showing a smaller decline in global health status in the radiotherapy group at 24 months. • Treatment-related adverse events were more frequent in the endocrine therapy group, with higher rates of arthralgia, fatigue, and hot flashes, leading to more treatment discontinuations. • Researchers suggest radiotherapy may be a less burdensome alternative, but emphasize the need for further data on disease control outcomes to draw definitive conclusions.

Daré Bioscience Advances Women's Health Portfolio with Funding and Clinical Progress

• Daré Bioscience is progressing its hormone-free contraceptive, Ovaprene, in a Phase 3 efficacy study, boosted by a foundation grant to expand clinical sites. • Sildenafil Cream 3.6% for female sexual arousal disorder is advancing towards Phase 3 after constructive FDA discussions on trial design and endpoints. • DARE-HPV, a novel treatment for HPV-related cervical diseases, is set for a Phase 2 trial, supported by a $10 million ARPA-H award. • Activities are underway for Phase 2 and Phase 1 studies of DARE-VVA1 and DARE-PTB1, respectively, targeting dyspareunia and preterm birth prevention.

Astellas' Fezolinetant Enters Phase 3 Trial for VMS in Breast Cancer Patients on Endocrine Therapy

• Astellas has initiated a Phase 3 trial (HIGHLIGHT 1) to evaluate fezolinetant for moderate to severe vasomotor symptoms (VMS) in breast cancer patients receiving adjuvant endocrine therapy. • The trial aims to enroll approximately 540 women with stage 0-3 hormone receptor-positive breast cancer across 100 global sites, comparing fezolinetant to placebo. • Fezolinetant, a nonhormonal oral medication, targets neurokinin B (NKB) to help restore balance in the brain's temperature control center, potentially reducing hot flashes and night sweats. • The primary endpoints of the HIGHLIGHT 1 study are changes in the frequency and severity of VMS at weeks 4 and 12, with treatment duration of 52 weeks and final evaluation at 55 weeks.
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