Banerji U, Dean EJ, Perez-Fidalgo JA, et al. The EORTC QLQ-C30 will be scored according to the EORTC QLQ-C30 Scoring Manual (Fayers et al. 2020 pii: S1470-2045(19)30817-4. A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Paclitaxel Versus Placebo + Paclitaxel as First-line Treatment for Patients with Histologically Confirmed, Locally Advanced (Inoperable) or Metastatic Triple negative Breast Cancer (TNBC)
Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week offtreatment within each 28-day treatment cycleProgression-Free Survival by investigator assessment (in accordance with RECIST 1.1)PFS2 - time from randomisation to second progression or deathResponse Rate (ORR) - percentage of patients with at least one investigator-assessed visit response of complete or partial response (as assessed by the investigator, using RECIST 1.1)Graded according to the National Cancer Institute (NCI CTCAE)Plasma PK parameters derived from a population model as data permitsThe self-administered instrument includes 23-items and yields 5 multi-item scores (body image, sexual functioning, arm symptoms, breast symptoms, and systemic therapy side effects). Targets. If you seek to connect and present your product or service to an engaged oncology healthcare community, you have come to the right place. You may purchase access to this article or login to access your subscription using the links below.Prior presentation: Data from this manuscript were partially reported at the San Antonio Breast Cancer Symposium (SABCS), December 5–9, 2017, San Antonio, Texas.Thank you for sharing this Clinical Cancer Research article.NOTE: We request your email address only to inform the recipient that it was you who recommended this article, and that it is not junk mail. Paclitaxel: Intravenous infusion. The rate of all-grade diarrhea was 35% and the rate of grade 3 to 5 diarrhea was 4% in the placebo arm. Capivasertib is a leading targeted inhibitor of the cancer-driving protein AKT, also known as PKB. This pilot phase I trial studies how well capivasertib with or without enzalutamide or fulvestrant work in treating patients with solid tumors with AKT1, AKT2, or AKT3 mutations that have spread to other places in the body or have come back.
AKT antagonist AZD5363 influences estrogen receptor function in endocrine-resistant breast cancer and synergizes with fulvestrant (ICI182780) in vivo. Capivasertib (AZD5363) plus fulvestrant versus placebo plus fulvestrant after relapse or progression on an aromatase inhibitor in metastatic ER-positive breast cancer (FAKTION): A randomized, double-blind, placebo-controlled, phase II trial. Capivasertib, a selective inhibitor of AKT, previously showed no benefit for patients with PIK3CA-mutant ER-positive metastatic breast cancer when combined with paclitaxel in … Prior fulvestrant or any inhibitor of the PI3K/Akt/mTOR pathway was prohibited.Baseline characteristics were well balanced between the 2 arms, with a median age of 61 years (range, 40-82) in the placebo arm and 62 years (range, 42-81) in the capivasertib arm. This trial could lead to a much-needed new option for some women with inoperable or metastatic breast cancer, which has spread to secondary sites and which can be challenging to treat.”“ICR researchers pioneered the idea of targeting AKT as a treatment for cancer and worked in close collaboration with colleagues in industry, setting the foundation for the subsequent creation of this new drug, and with our colleagues at The Royal Marsden to take it to patients.“It’s very exciting to see a drug discovered and developed thanks to our research now being studied in major phase III trials, which if successful could deliver an urgently needed new option for women whose breast cancer has become resistant to current treatments.”The ONA Editor curates oncology news, views and reviews from Australia and around the world for our readers. 2001). The trial will compare the effectiveness of capivasertib combined with fulvestrant, a current hormone treatment, against a placebo with fulvestrant. Background. About one-fourth had prior chemotherapy for metastatic disease. The costs of publication of this article were defrayed in part by the payment of page charges. Capivasertib is a potent and selective inhibitor of Akt 1-3 isoforms. Capivasertib is a potent and selective inhibitor of Akt 1-3 isoforms. The protein is a key node in a signalling network that becomes dysregulated in a range of cancers and helps to drive the disease.ICR scientists revealed the 3D structure of AKT before researchers at the ICR’s The initial clinical development of capivasertib was centred on an early-stage trial which was led by the ICR and its partner hospital The launch of the CAPItello-291 trial follows the announcement of the initial results of a phase II trial called ER-positive, HER2-negative breast cancer cells have copies of the oestrogen receptor – allowing them to grow in the presence of oestrogen – but do not over-produce copies of the human epidermal growth factor (HER2).This subtype of breast cancer is often driven by activation of AKT and, once the disease has relapsed or spread, current treatment options are limited.The launch of CAPItello-291 follows the recent launch of the similarly named The results of the phase II trials of capivasertib indicate that it has the potential to be an option for sub-groups of women whose cancers do not respond to other therapies.The ICR runs the world’s most successful academic drug discovery programme in oncology, having discovered 20 new drug candidates since 2005.