 |
114 Diseases |  |
361 Trials |
|
361 Trials |  |
7200 News |  |
| «12...6162636465666768697071...100101» |
- Ibrance (palbociclib) / Pfizer
Examining Ibrance (palbociclib) + anti-estrogen therapy outcomes if concomitantly dispensed at a specialty pharmacy vs. retail pharmacy () - May 6, 2020 - Abstract #AMCP2020AMCP_42;
If goal of palbociclib therapy is progression free survival, dispensing both palbociclib and concomitant therapy together at a SP showed clinical significance and could help improve patient outcomes. Sponsorship: None
- letrozole / Generic mfg., Kisqali (ribociclib) / Novartis
[VIRTUAL] BioItaLEE: Comparative biomarker analysis of liquid biopsies and paired tissue samples of patients treated with ribociclib and letrozole as first-line therapy for advanced breast cancer (aBC) (ePosters) - May 5, 2020 - Abstract #ESMOBCI2020ESMO_BC_I_567;
P3
The ultra-deep NGS of TS in this study, enabled improved comparison between TS and LB. LB+ findings with TS- results were infrequent.
- letrozole / Generic mfg., Kisqali (ribociclib) / Novartis
[VIRTUAL] BioItaLEE: Comparative biomarker analysis of liquid biopsies and paired tissue samples of patients treated with ribociclib and letrozole as first-line therapy for advanced breast cancer (aBC) (ePosters) - May 5, 2020 - Abstract #ESMOBCI2020ESMO_BC_I_501;
P3
The ultra-deep NGS of TS in this study, enabled improved comparison between TS and LB. LB+ findings with TS- results were infrequent.
- letrozole / Generic mfg.
[VIRTUAL] Independent validation of the PAM50-based chemoendocrine score (CES) as pathologic complete response (pCR) and disease-free survival (DFS) predictor in hormone receptor (HR)+/HER2+ breast cancer (BC) (ePosters) - May 5, 2020 - Abstract #ESMOBCI2020ESMO_BC_I_500;
P2, P2b, P
Funding: FSEOM Scholarships for Research Training in Reference Centers Abroad 2018 (TP). SEOM Foundation, FSEOM Scholarships for Research Training in Reference Centers Abroad 2016 (AF-M).
- paclitaxel / Generic mfg., doxorubicin hydrochloride / Generic mfg., cyclophosphamide intravenous / Generic mfg.
DRUG-INDUCED LIVER INJURY DUE TO CHEMOTHERAPEUTIC AGENTS AND OTHER CANCER MEDICATIONS. A POPULATION BASED STUDY. () - May 4, 2020 - Abstract #DDW2020DDW_4226;
The most commonly implicated agents were pazopanib and docetaxel. Most patients were switched to another treatment which potentially affected prognosis, however there were no cases of severe liver injury
- | Faslodex (fulvestrant) / AstraZeneca
Review, Journal: Fulvestrant for Untreated Hormone-Receptor Positive Locally Advanced or Metastatic Breast Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal. (Pubmed Central) - May 2, 2020
The economic model was sensitive to changes in overall survival and the Evidence Review Group considered the incremental cost-effectiveness ratio was uncertain and likely to increase once mature results from FALCON become available. The National Institute for Health and Care Excellence Appraisal Committee concluded that fulvestrant could not be recommended for treating locally advanced or metastatic estrogen-receptor-positive breast cancer in postmenopausal women who have not received previous endocrine therapy.
- || metformin / Generic mfg.
Clinical, Review, Journal: Metformin for ovulation induction (excluding gonadotrophins) in women with polycystic ovary syndrome. (Pubmed Central) - May 1, 2020
No studies reported gastrointestinal side effects in this comparison. Due to the low quality of the evidence, we are uncertain of the effect of metformin on miscarriage in all three comparisons.
- | letrozole / Generic mfg., anastrozole / Generic mfg.
Enrollment open: Anastrozole and Letrozole After Surgery for the Treatment of Stage I-III Breast Cancer (clinicaltrials.gov) - Apr 29, 2020
P2, N=29, Recruiting, Sponsor: Mayo Clinic
Due to the low quality of the evidence, we are uncertain of the effect of metformin on miscarriage in all three comparisons. Not yet recruiting --> Recruiting
- Kisqali (ribociclib) / Novartis
[VIRTUAL] EARLY real-world treatment and dosing patterns of ribociclib for metastatic breast cancer (mBC): A retrospective observational study. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_2921;
Early utilization demonstrates patients receiving ribociclib are older and sicker than those in pivotal clinical trials. Substantial heterogeneity in ribociclib initiation by LOT was observed.
- Ibrance (palbociclib) / Pfizer
[VIRTUAL] Palbociclib in hormone positive metastatic breast cancer: A real world multicenter Indian experience. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_2919;
Neutropenia was the commonest side effect, which was uncomplicated and easily managed with dose delays. Using CDK4/6 inhibitors with hormonal therapy has become the standard of care in HR+ MBC Indian patients.
- letrozole / Generic mfg., Kisqali (ribociclib) / Novartis
[VIRTUAL] Retrospective analysis of ribociclib and letrozole as first-line therapy in patients with hormone receptor (HR) positive metastatic breast cancer (MBC) within a managed access program (MAP) in Turkey. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_2917;
The efficacy and toxicity of first-line ribociclib and letrozole within Turkish MAP is similar to the results from randomized clinical studies for patients with HR positive, Her-2 negative MBC. Research Funding: None
- Ibrance (palbociclib) / Pfizer
[VIRTUAL] Real-world survival data of palbociclib in advanced and metastatic breast cancer: A multicenter experience in Lebanon. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_2916;
We are the first to describe these characteristics. Our result (PFS 26 2.6 months) is in conformity with the PFS obtain with PALOMA-2 (24 months).
- Ibrance (palbociclib) / Pfizer, letrozole / Generic mfg., Faslodex (fulvestrant) / AstraZeneca
[VIRTUAL] Tolerance of concurrent CDK inhibitor and radiation therapy in metastatic breast cancer patients. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_2801;
Given this experience, palbociclib should not be discontinued during radiation therapy. Nevertheless, our findings should be confirmed in prospective registration studies collecting larger number of patients.
- letrozole / Generic mfg.
[VIRTUAL] Five year letrozole versus placebo in BRCA1/2 germline mutations carriers: Final results of LIBER, a double-blind randomized phase III breast cancer prevention trial. (Poster Board 26) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1880;
P3
However, the study was underpowered (170 of 270 pts expected). Despite no differences in safety and quality of life, drop-out rate was high in both P and L arms.
- SAR439859 / Sanofi, letrozole / Generic mfg.
[VIRTUAL] Phase II preoperative window study of SAR439859 versus letrozole in post-menopausal women with newly diagnosed estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. (Poster Board 193) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1830;
P1/2, P2
The study is currently recruiting; target enrollment: n = 126. Research Funding: Sanofi
- Votrient (pazopanib) / Novartis
[VIRTUAL] Pazopanib (PZ) plus endocrine therapy as treatment for hormone resistant advanced breast cancer (ABC). (Poster Board 153) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1792;
These results support clinical efficacy of antiangiogenic TKI in HR+ ABC, and suggest benefit in hormone resistant disease. Expected toxicities resulted in early discontinuation in 28.6%, which limited drug exposure.
- [VIRTUAL] Meta-analysis of cyclin-dependent kinase (CDK) 4/6 inhibitors with endocrine therapy versus endocrine therapy alone on progression-free survival (PFS) and overall survival (OS) for metastatic breast cancer (MBC). (Poster Board 145) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1784;
The result of our meta-analysis confirms the previously reported PFS benefit from CDK 4/6 inhibitors plus ET and shows an OS benefit when including RCTs of all 3 CDK 4/6 inhibitors for the treatment of HR+/HER2- MBC. (NSAI: Non steroidal aromatase inhibitor; Palbo: Palbociclib; Let: Letrozole; Ful:Fulvestrant; Ribo: Ribociclib; Abem: Abemaciclib; P: Placebo) Research Funding: None
- letrozole / Generic mfg., Kisqali (ribociclib) / Novartis
[VIRTUAL] Updated results from the phase IIIb complement-1 study of ribociclib (RIB) plus letrozole (LET) in the treatment of HR+, HER2-advanced breast cancer (ABC). (Poster Board 140) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1780;
P3
Safety and efficacy data were consistent with those observed in the MONALEESA trials, supporting the use of RIB+LET in the first-line setting. NCT02941926.
- Ibrance (palbociclib) / Pfizer, gedatolisib (PF-05212384) / Curie Institute, Pfizer
[VIRTUAL] Biomarker analysis from a phase I study using gedatolisib+palbociclib+hormone therapy in ER+/HER2- metastatic breast cancer (mBC). (Poster Board 137) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1777;
P1b
Somatic frequency changes of PI3K pathway alterations were most correlated with clinical response. Genomic data analysis from dose expansion samples is currently ongoing.
- letrozole / Generic mfg., Lenvima (lenvatinib) / Eisai, Merck (MSD)
[VIRTUAL] Clinical efficacy and molecular effects of lenvatinib (Len) and letrozole (Let) in hormone receptor-positive (HR+) metastatic breast cancer (MBC). (Poster Board 104) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1746;
P2
The results support further investigation in randomized studies. Tumor profiling identified mutations associated with response and insights on molecular effects of lenvatinib.
- Ibrance (palbociclib) / Pfizer, letrozole / Generic mfg., Faslodex (fulvestrant) / AstraZeneca
[VIRTUAL] PARSIFAL: A randomized, multicenter, open-label, phase II trial to evaluate palbociclib in combination with fulvestrant or letrozole in endocrine-sensitive patients with estrogen receptor (ER)[+]/HER2[-] metastatic breast cancer. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_1735;
P2
As both arms demonstrated comparable 4 years-OS, PF is a reasonable alternative to PL in this setting. Research Funding: Pfizer
- Piqray (alpelisib) / Novartis, Faslodex (fulvestrant) / AstraZeneca
[VIRTUAL] Alpelisib (ALP) + fulvestrant (FUL) in patients (pts) with PIK3CA-mutated (mut) hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC) previously treated with cyclin-dependent kinase 4/6 inhibitor (CDKi) + aromatase inhibitor (AI): BYLieve study results. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_1734;
P2
Building on findings from SOLAR-1, BYLieve further supports use of ALP + FUL for HR+, HER2–PIK3CA-mut ABC. Research Funding: Novartis Pharmaceuticals Corporation
- letrozole / Generic mfg., Eligard (leuprolide acetate) / TOLMAR, Astellas, Sanofi
[VIRTUAL] Personalized neoadjuvant strategy in luminal A breast cancer to increase breast conserving surgery (BCS) rate [PLATO study]. (Poster Board 95) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1720;
P2
The secondary endpoint is actual breast conservation rate, pathologic complete response, clinical response rate, and disease-free survival. Research Funding: Agendia Inc., Pharmaceutical/Biotech Company.
- letrozole / Generic mfg.
[VIRTUAL] Genome-wide association study of steady-state letrozole concentration in patients with breast cancer. (Poster Board 30) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1660;
If letrozole concentrations affect treatment efficacy or toxicity, CYP2A6 genetics may be useful to individualize letrozole dosing to improve clinical outcomes in patients with HR+ breast cancer. Research Funding: Breast Cancer Research Foundation
- [VIRTUAL] Early-stage breast cancer (BC) patients: Factors associated with aromatase inhibitor-induced musculoskeletal symptoms. (Poster Board 17) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1647;
24% of these changed, held or discontinued AI regimen due to severe AIMSS. Higher BMI at diagnosis was associated with a higher risk of AIMSS.
- letrozole / Generic mfg., tamoxifen / Generic mfg.
[VIRTUAL] Breast Cancer Index (BCI) predicts benefit of two-and-a-half versus five years of extended endocrine therapy in HR+ breast cancer patients treated in the IDEAL trial. (Poster Board 4) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1631;
P3
These results support the growing body of evidence that BCI by H/I status predicts preferential endocrine response in distinct subgroups of patients, and further support its role as an important genomic tool to inform the risk-benefit regarding duration of extended endocrine therapy. Research Funding: Biotheranostics, Inc.
- letrozole / Generic mfg., Kisqali (ribociclib) / Novartis
[VIRTUAL] Letrozole + ribociclib versus letrozole + placebo as neoadjuvant therapy for ER+ breast cancer (FELINE trial). () - Apr 29, 2020 - Abstract #ASCO2020ASCO_1621;
P2
At D14C1 twice as many women on L+R had CCCA compared to L+P (92% vs 52%). However, significantly more women on L+R had increased proliferation between D14C1 and surgery, resulting in similar CCCA at surgery.
- Avastin (bevacizumab) / Roche, paclitaxel / Generic mfg.
[VIRTUAL] Ranking of therapeutic regimens for hormone receptor-positive, HER2-negative, metastatic breast cancer (MBC) using information theoretic network meta-analysis. (Poster Board 42) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1231;
Our ranking result is similar to previous studies with a notably larger number of comparisons (Giuliano et al. is the largest published study, with 131 regimens/50,029 pts analyzed).
- | letrozole / Generic mfg.
Enrollment closed: Does Letrozole Improve Pregnancy Outcome in Fresh Embryo Transfer IVF/ICSI Cycle? (clinicaltrials.gov) - Apr 28, 2020
P4, N=300, Active, not recruiting, Sponsor: National Taiwan University Hospital
is the largest published study, with 131 regimens/50,029 pts analyzed). Not yet recruiting --> Active, not recruiting
- | Herceptin (trastuzumab) / Roche
Enrollment closed: ARETTA: Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer (clinicaltrials.gov) - Apr 28, 2020
P2, N=60, Active, not recruiting, Sponsor: University of Chicago
Not yet recruiting --> Active, not recruiting Not yet recruiting --> Active, not recruiting
- ||| letrozole / Generic mfg., tamoxifen / Generic mfg.
Clinical, P3 data, Journal, Gene Signature: Independent Validation of EarlyR Gene Signature in BIG 1-98: A Randomized, Double-Blind, Phase III Trial Comparing Letrozole and Tamoxifen as Adjuvant Endocrine Therapy for Postmenopausal Women With Hormone Receptor-Positive, Early Breast Cancer. (Pubmed Central) - Apr 28, 2020
EarlyR identifies a set of high-risk patients with relatively poor prognosis who may be considered for additional treatment. Further studies will focus on analyzing the predictive value of EarlyR signature.
- ||| Piqray (alpelisib) / Novartis
Trial completion, Metastases: BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer (clinicaltrials.gov) - Apr 28, 2020
P1, N=52, Completed, Sponsor: Memorial Sloan Kettering Cancer Center
Further studies will focus on analyzing the predictive value of EarlyR signature. Active, not recruiting --> Completed
- || Kisqali (ribociclib) / Novartis
Trial completion date, Combination therapy, Metastases: Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer. (clinicaltrials.gov) - Apr 27, 2020
P2, N=315, Recruiting, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Completed Trial completion date: Apr 2022 --> Dec 2023
- | letrozole / Generic mfg.
New P4 trial: Endometrial Preparation by Short Course of Letrozole Before Hysteroscopic Removal of Endocavitary Lesions (clinicaltrials.gov) - Apr 27, 2020
P4, N=30, Not yet recruiting, Sponsor: Mansoura University
- || letrozole / Generic mfg., exemestane / Generic mfg.
Clinical, Journal: The NEOLETEXE trial: a neoadjuvant cross-over study exploring the lack of cross resistance between aromatase inhibitors. (Pubmed Central) - Apr 23, 2020
Here, we present the NEOLETEXE trial with the aim of exploring the individual mechanisms involved behind the observed lack of cross resistance. Clinical trial registration: The trial has been approved by the Regional Ethics Committee of South-East Norway (project number 2015/84).
- | letrozole / Generic mfg., clomifene citrate / Generic mfg.
New P1 trial, HEOR, Cost effectiveness: Cost Effectiveness Analysis for Induction of Ovulation in the Polycystic Ovary Syndrome by Letrozole Versus Clomiphene Citrate (clinicaltrials.gov) - Apr 23, 2020
P1, N=212, Not yet recruiting, Sponsor: Assiut University
- || letrozole / Generic mfg.
Clinical, Journal: Late Recurrence of Breast Cancer 32 Years after Surgery-A Case Report (Pubmed Central) - Apr 23, 2020
She started letrozole but the disease had progressed 6 months later. We experienced a case of late breast cancer recurrence 32 years after surgery.
- || Halaven (eribulin mesylate) / Eisai
Clinical, Journal: A Case of Advanced Breast Cancer with Altered Biology by Eribulin Chemotherapy (Pubmed Central) - Apr 23, 2020
Subsequent treatment with eribulin was started, and partial response was obtained; however, new lymph node metastasis developed in the axilla after 11 cycles. The primary tumor and axillaryly mph nodes showed stronglypositive ER expression, were PgR-negative and HER2-positive, and showed Ki-67 low expression and HER2-positive conversion.
- Mekinist (trametinib) / Novartis, paclitaxel / Generic mfg.
[VIRTUAL] A Randomized Phase II/III Study to Assess the Efficacy of Trametinib in Patients with Recurrent or Progressive LowGrade Serous Ovarian or Peritoneal Cancer () - Apr 23, 2020 - Abstract #SGOI2020SGO_I_17;
Patients were randomized 1:1 to receive either TRAM 2 mg daily or 1 of 5 SOC options (weekly paclitaxel, PLD, topotecan, letrozole, or tamoxifen) until disease progression. Compared to physician’s choice SOC, TRAM was associated with significantly improved PFS and ORR in women with recurrent LGSOC.
- || ....so other than the Zometa infusions, that is five years of monthly in person visits that could have been done via telemedicine. (I was on tamoxifen and then femara). currently on Abraxane 3x a month so of course I have to be there in person now (Twitter) - Apr 22, 2020
- | letrozole / Generic mfg.
Journal: The Role of Anti-Müllerian Hormone in Testis Differentiation Reveals the Significance of the TGF-β Pathway in Reptilian Sex Determination. (Pubmed Central) - Apr 22, 2020
Moreover, Amh was rapidly up-regulated during female-to-male sex reversal induced by aromatase inhibitor letrozole. Most importantly, Amh loss of function by RNA interference led to complete feminization of genetic male (ZZ) gonads, suppression of the testicular marker Sox9, and upregulation of the ovarian regulator Cyp19a1 Conversely, overexpression of Amh in ZW embryos resulted in female-to-male sex reversal, characterized by the formation of a testis structure, ectopic activation of Sox9, and a remarkable decline in Cyp19a1 Collectively, these findings provide the first solid evidence that Amh is both necessary and sufficient to drive testicular development in a reptilian species, P. sinensis, highlighting the significance of the TGF-β pathway in reptilian sex determination.
- | letrozole / Generic mfg.
New P3 trial: Protocols of IVF/ICSI in Poor Responders (clinicaltrials.gov) - Apr 21, 2020
P3, N=134, Not yet recruiting, Sponsor: Cairo University
- | letrozole / Generic mfg.
Journal: Functional Profiling of FSH and Estradiol in Ovarian Granulosa Cell Tumors. (Pubmed Central) - Apr 21, 2020
Letrozole suppressed E2 production in AGCTs; however, it did not impact cell viability. We did not find preclinical evidence to support the clinical use of aromatase inhibitors in AGCT treatment, and thus randomized, prospective clinical studies are needed to clarify the role of hormonal treatments in AGCTs.
- || Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy, Metastases: BOLERO-5: A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor (clinicaltrials.gov) - Apr 21, 2020
P2, N=159, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
We did not find preclinical evidence to support the clinical use of aromatase inhibitors in AGCT treatment, and thus randomized, prospective clinical studies are needed to clarify the role of hormonal treatments in AGCTs. Recruiting --> Active, not recruiting | Trial completion date: Sep 2021 --> Jul 2022 | Trial primary completion date: Dec 2019 --> Sep 2020
- | Verzenio (abemaciclib) / Eli Lilly
Trial initiation date, Trial suspension, Metastases: AMBRE: Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer (clinicaltrials.gov) - Apr 20, 2020
P3, N=378, Suspended, Sponsor: UNICANCER
Recruiting --> Active, not recruiting | Trial completion date: Sep 2021 --> Jul 2022 | Trial primary completion date: Dec 2019 --> Sep 2020 Initiation date: Jan 2020 --> May 2020 | Not yet recruiting --> Suspended
- | letrozole / Generic mfg.
Journal: The Degree of Sex Reversal in Muscovy Ducks (Cairina moschata domestica) Induced by an Aromatase Inhibitor. (Pubmed Central) - Apr 19, 2020
Letrozole can induce female Muscovy ducks to convert into males, but the reversal cannot be completed. Thus, further studies are needed to elucidate how to entirely attain the change.
- ||| letrozole / Generic mfg.
Clinical, P3 data, Journal: Use of letrozole after aromatase inhibitor-based therapy (NRG Oncology/NSABP B-42): a randomised, double-blind, placebo-controlled phase 3 trial. (Pubmed Central) - Apr 17, 2020
P3
After 5 years of aromatase inhibitor-based therapy, 5 years of letrozole therapy did not significantly prolong disease-free survival compared with placebo. Careful assessment of potential risks and benefits is required before recommending extended letrozole therapy to patients with early-stage breast cancer.
- ||| letrozole / Generic mfg.
Welp, it has taken a few but I am surgically post menopause (brca1) but am having fairly good luck on letrozole. And my best advice is keep your body moving, especially when you don’t want to move (Twitter) - Apr 17, 2020
- || Avastin (bevacizumab) / Roche
Trial completion date, Trial primary completion date, Combination therapy: Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer (clinicaltrials.gov) - Apr 17, 2020
P2, N=75, Active, not recruiting, Sponsor: University of Alabama at Birmingham
Careful assessment of potential risks and benefits is required before recommending extended letrozole therapy to patients with early-stage breast cancer. Trial completion date: Jan 2020 --> Jan 2021 | Trial primary completion date: Jan 2020 --> Jan 2021
- Ibrance (palbociclib) / Pfizer, letrozole / Generic mfg.
[VIRTUAL] Real-world tumour response of palbociclib plus letrozole vs letrozole for metastatic breast cancer in US clinical practices (ePosters) - Apr 17, 2020 - Abstract #ESMOBCI2020ESMO_BC_I_460;
Acknowledging the limitations of real-world data and absence of scheduled tumor assessments in routine practice, this finding supports the use of palbociclib in combination with endocrine therapy as standard of care for HR+/HER2- MBC.Legal entity responsible for the study: Pfizer Inc. Funding: Pfizer Inc.