Abstract OT2-01-21: Phase 2 study of investigational TORC1/2 inhibitor TAK-228 with fulvestrant in women with ER-positive/HER2-negative advanced or metastatic breast cancer that has progressed during or after aromatase inhibitor therapy

This study will test whether fulvestrant plus TAK-228, a dual TORC1/2 inhibitor, can overcome endocrine therapy resistance in ER-positive breast cancer. This is an open-label, randomized, 3-arm, phase 2 study of continuous once-daily TAK-228 (oral, 4 mg) or once-weekly TAK-228 (oral, 30 mg) plus fulvestrant (500 mg intramuscularly on d1 and d15 of cycle 1 [loading regimen] then d1 of each subsequent 28-d cycle), compared with fulvestrant alone, in pts with advanced or metastatic ER-positive/HER2-negative breast cancer that has progressed during/after AI therapy. Pts will be randomized 1:1:1 to the 3 arms and stratified at randomization via presence or absence of visceral metastasis, prior hormonal therapy sensitivity, and prior exposure to CDK 4/6 inhibitors. Pts will receive study drug(s) until progressive disease (PD), unacceptable toxicity, or consent withdrawal. Postmenopausal women ≥18 yrs old with local histological confirmation of ER-positive/HER2-negative metastatic or advanced breast cancer; with measureable disease; ECOG status 0–1; PD during/after prior AI therapy (defined as progression ≤12 mos after discontinuing adjuvant therapy or ≤1 mo after discontinuation in the metastatic setting) and adequate organ function are eligible. Exclusion criteria include prior therapy with mTOR inhibitors, PI3K inhibitors, dual PI3K-mTOR inhibitors, AKT inhibitors, or fulvestrant; prior treatment with>1 line of chemotherapy for metastatic breast cancer; experien...
Source: Cancer Research - Category: Cancer & Oncology Authors: Tags: Ongoing Clinical Trials Source Type: research

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CONCLUSION: This was the first pre‑surgical study to demonstrate that an oral SERD impacts its key biological targets. However, AZD9496 was not superior to fulvestrant at the dose tested. PMID: 32234755 [PubMed - as supplied by publisher]
Source: Clinical Cancer Research - Category: Cancer & Oncology Authors: Tags: Clin Cancer Res Source Type: research
AbstractBreast cancer is a disease of aging, and the incidence of breast cancer is projected to increase dramatically as the global population ages. The majority of breast cancers that occur in older adults are hormone-receptor positive, human epidermal growth factor receptor-2 (HER2)-negative phenotypes, with favorable tumor biology; yet, because of underrepresentation in clinical trials, less evidence is available to guide the complex care for this population. Providing care for older patients with metastatic breast cancer, with coexisting medical conditions, increased risk of treatment toxicity, and frailty, remains a c...
Source: Drugs and Aging - Category: Geriatrics Source Type: research
Conclusions: While prospective studies are needed to confirm our findings, the potential OS advantage of CV over single-agent C in HR+ mBC patients must be weighed against a significantly higher incidence of AEs.
Source: Cancers - Category: Cancer & Oncology Authors: Tags: Article Source Type: research
Condition:   Breast Neoplasms Intervention:   Drug: DZD3969 Sponsor:   Dizal (Jiangsu) Pharmaceutical Co., Ltd. Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
This article presents a critical appraisal of two treatments commonly used in the treatment of metastatic HER2-positive breast cancer: the oral chemotherapy drug, capecitabine, and the monoclonal antibody, trastuzumab. What follows is a critical discussion of the pharmacotherapeutics of capecitabine and trastuzumab, which considers their use both as single agents and as a combination regimen in the treatment of metastatic breast cancer. The implications of side effects of these drugs are discussed, both individually and in combination, as are the challenges these bring to the prescriber. The article evaluates the use of th...
Source: British Journal of Nursing - Category: Nursing Authors: Tags: Br J Nurs Source Type: research
In metastatic breast cancer, top news at SABCS 2019 focused on two highly active drugs in HER2+ disease, an oral paclitaxel in TNBC, and evidence for a new standard front-line therapy in HR+ disease.Medscape
Source: Medscape Today Headlines - Category: Consumer Health News Tags: None ReCAP Source Type: news
The investigational oral therapy tucatinib, when added to standard trastuzumab and capecitabine, resulted in a"clinically meaningful" lower risk of disease progression or death compared with placeboMedscape Medical News
Source: Medscape Hematology-Oncology Headlines - Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news
Adjuvant therapy with S-1, an oral fluoropyrimidine-based drug, plus endocrine therapy postoperatively significantly increased invasive disease-free survival (IDFS) in patients with HR-positive, HER2-negative breast cancer.
Source: CancerNetwork - Category: Cancer & Oncology Authors: Source Type: news
Conclusion.Irinotecan and etoposide demonstrated only modest clinical activity and poor tolerability in patients with MBC refractory to anthracycline, taxane, and capecitabine therapy. Further studies testing a lower dose and/or different schedule could be considered given ease of administration and responses seen.
Source: The Oncologist - Category: Cancer & Oncology Authors: Tags: Breast Cancer, Chinese Edition, Clinical Trial Results Source Type: research
In this study, Her2, MUC1, and a novel fusion structure were expressed in the seeds and hairy roots of transgenic plants appropriately. The mice groups were immunized either by feeding of transgenic seeds or hairy roots. All immunized groups showed a considerable rise in anti-glycoprotein serum IgG and IgA, and IFNɣ cytokine. However, the animals received chimeric protein showed significant higher immune responses in comparison to ones received one of these immunogen. The results indicated that the oral immunization of an animal model with transgenic plants could effectively elicit immune responses against two major ...
Source: Iranian Journal of Allergy, Asthma and Immunology - Category: Allergy & Immunology Authors: Tags: Iran J Allergy Asthma Immunol Source Type: research
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