- |||||||||| Piqray (alpelisib) / Novartis, Kisqali (ribociclib) / Novartis
Trial completion date, Trial primary completion date, Metastases: CLEE011X2107: Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer (clinicaltrials.gov) - Oct 22, 2021 P1/2, N=256, Active, not recruiting, Further large randomized controlled trials are needed to confirm our findings. Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Nov 2022
- |||||||||| Piqray (alpelisib) / Novartis
Trial completion date, Metastases: BYLieve: Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments (clinicaltrials.gov) - Oct 21, 2021 P2, N=382, Active, not recruiting, Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Nov 2022 Trial completion date: Jan 2023 --> Jul 2023
- |||||||||| NN1213 / Novo Nordisk
Enrollment closed, Enrollment change, Metastases: POLLY: ER Reactivation Therapy for Breast Cancer (clinicaltrials.gov) - Oct 18, 2021 P2, N=19, Active, not recruiting, Pfizer Inc (NCT01740427). Recruiting --> Active, not recruiting | N=29 --> 19
- |||||||||| tamoxifen / Generic mfg.
Review, Journal: Review of the Literature on Ocular Complications Associated With Aromatase Inhibitor Use. (Pubmed Central) - Oct 15, 2021 Aromatase inhibitors (AIs), such as anastrozole, letrozole, and exemestane, are commonly used as adjuvant endocrine therapy in hormone-receptive breast cancer in postmenopausal women...The ocular side effects of tamoxifen use are well documented and were not included...Although these are likely rare side effects, we recommend a high level of clinical suspicion when assessing patients with visual symptoms and on AIs. Larger prospective studies are necessary to further investigate these complications.
- |||||||||| tamoxifen / Generic mfg.
A phase 2 study of chemotherapy de-escalation using a pathological response-guided strategy in patients with HER2-positive, low-risk early breast cancer: PHERGain-2 (Hall 1) - Oct 9, 2021 - Abstract #SABCS2021SABCS_278; Background: The introduction of trastuzumab (H) and pertuzumab (P) and ado-trastuzumab emtansine (T-DM1) has drastically improved clinical outcomes in patients (pts) with HER2-positive early breast cancer, allowing to explore chemotherapy-sparing approaches in this population...Hormone receptor-positive pts will be additionally given letrozole (2.5 mg/day orally) if postmenopausal or tamoxifen (20 mg/day orally) plus gonadotropin-releasing hormone analogue if pre-/peri-menopausal or men...The analysis for the primary efficacy and safety endpoints will be conducted with 95% confidence intervals based on Kaplan-Meier estimator. This trial was opened to accrual in May 2021.
- |||||||||| paclitaxel / Generic mfg.
Escalating and de-escalation - titrating the right regimen in early stage HER2 positive (Stars at Night Ballroom 1&2) - Oct 9, 2021 - Abstract #SABCS2021SABCS_40; Regarding de-escalation, TBCRC0023, one of the first chemotherapy-free de-escalation studies in HER2+ EBC, looked at duration of neoadjuvant trastuzumab and lapatinib - in HR+ tumors together with letrozole (+ GNRH if premenopausal)...In TP II, 12x weekly paclitaxel + trastuzumab + pertuzumab achieved a total pCR rate of 57%, whereas the antibodies alone + ET rendered 24%...As demonstrated in ADAPT TP, HER2-enriched subtype is associated with high pCR rates after HER-targeting regimens whereas luminal A and B subtypes have lower pCR rates. In luminal tumors, survival endpoints may thus be more appropriate to fully evaluate de-escalated regimens.In clinical routine, individualized therapy concepts including therapy de-escalation and escalation should always be evidence-based in order not to jeopardize the already excellent survival rates we have achieved over the last decade in HR+ HER2+ EBC.
- |||||||||| letrozole / Generic mfg., clomifene citrate / Generic mfg.
Clinical, Journal: A comparison of oral versus injectable ovarian stimulation in IUI in women ≥38 years of age with decreased ovarian reserve. (Pubmed Central) - Oct 8, 2021 The findings reveal that COH/IUI in older women with decreased ovarian reserve is a viable option (clinical pregnancy rate of 7.5% per cycle), and suggest that oral stimulation agents may be the first-line option, with letrozole having conferred the highest clinical pregnancy rate, 9.1%, which is notable given the typical poor fecundability of this population. However, larger population studies are needed to support this.
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