View Post

Pyrotinib plus capecitabine versus lapatinib plus capecitabine for the treatment of HER2-positive metastatic breast cancer (PHOEBE)

In Clinical Trials by Barbara Jacoby

From: thelancet.com A multicentre, open-label, randomised, controlled, phase 3 trial Background Despite therapeutic advances in HER2-positive metastatic breast cancer, resistance to trastuzumab inevitably develops. In the PHOEBE study, we aimed to assess the efficacy and safety of pyrotinib (an irreversible pan-HER inhibitor) plus capecitabine after previous trastuzumab. Methods This is an open-label, randomised, controlled, phase 3 trial done at 29 …

View Post

Optiscan Imaging (ASX:OIL) begins stage three of breast cancer study

In Clinical Trials by Barbara Jacoby

By: Julia Seymour From: themarketherald.com Optiscan Imaging (OIL) has begun stage three of its breast cancer study in Melbourne. The study will involve 20 breast cancer patients at Royal Melbourne Hospital, Frances Perry House and Epworth Hospital using Optiscan’s FIVE2/Viewnvivo endomicroscope. The Optiscan endomicroscope enables real-time, 3D, ‘in vivo’ imaging of human tissue at the cellular level, providing instant virtual …

View Post

Circulating Tumor Cell Count Reliable in Determining Best Treatment Approach for Metastatic Breast Cancer

In Clinical Trials by Barbara Jacoby

From: journalofclinicalpathways.com Circulating tumor cell count is a reliable biomarker for choosing between chemotherapy or endocrine therapy for patients with HER2-negative metastatic breast cancer, according to a recent study published in JAMA Oncology (2020 Nov 5. doi:10.1001/jamaoncol.2020.5660). “The choice between chemotherapy and endocrine therapy as first-line treatment for [HER2-negative] metastatic breast cancer is usually based on the presence of clinical …

View Post

Dr. Kalinsky on Initial Results of the RxPONDER Trial in HR+/HER2- Breast Cancer

In Clinical Trials by Barbara Jacoby

By: Kevin Kalinsky, MD, MS From: onclive.com Kevin Kalinsky, MD, MS, director of the Glenn Family Breast Center and Breast Medical Oncology at Winship Cancer Institute, and acting associate professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine, discusses the initial results of the phase 3 RxPONDER trial in patients with hormone receptor (HR)–positive, …

View Post

FDA Approves Margetuximab-cmkb Plus Chemo in Pretreated Metastatic HER2+ Breast Cancer

In In The News by Barbara Jacoby

By: Kristi Rosa From: onclive.com The FDA has approved margetuximab-cmkb (Margenza) in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have previously received 2 or more anti-HER2 regimens, at least one of which for metastatic disease.1 The regulatory decision was based on findings from the phase 3 SOPHIA trial (NCT02492711), in which the …

View Post

Gilead Advances Oncology Portfolio With New Data From Phase 3 ASCENT Trial of Trodelvy® in Metastatic Triple Negative Breast Cancer

In Clinical Trials by Barbara Jacoby

From: .businesswire.com Gilead Sciences, Inc. (Nasdaq: GILD) is presenting new data from the Phase 3 ASCENT trial of Trodelvy® (sacituzumab govitecan-hziy) in metastatic triple-negative breast cancer (mTNBC) at the 2020 San Antonio Breast Cancer Symposium being held virtually December 8-11, 2020. The new data and analyses from the ASCENT trial continue to demonstrate the high clinical activity of Trodelvy in …

View Post

Updated Outcome and Treatment Benefit Data from MINDACT Study Reinforce Real-World Value of MammaPrint® for Clinical Low Risk Breast Cancer Patients

In Clinical Trials by Barbara Jacoby

From: businesswire.com Agendia, Inc., a world leader in precision oncology for breast cancer, today announced that additional data from its groundbreaking MINDACT study will be highlighted in an oral presentation by Laura van ’t Veer, Ph.D., Co-founder and Chief Research Officer, at the 2020 San Antonio Breast Cancer Symposium (SABCS 2020). These data highlight the ability of MammaPrint®, Agendia’s 70-gene …

View Post

Phase 3 DETECT III Study Suggests CTC Count to be Possible Biomarker for HER2-Directed Therapy in MBC

In Clinical Trials by Barbara Jacoby

By: Dylann Cohn-Emery From: cancernetwork.com The study found that favorable outcomes after treatment with lapatinib (Tykerb) were demonstrated by early declines in circulating tumor cell counts (CTCs) in patients with metastatic breast cancer who initially had HER2-negative primary tumors but positive HER2 CTCs. Data from the phase 3 DETECT III study (NCT01619111) showed favorable outcomes after treatment with the HER2-directed …

View Post

BeyondSpring Announces New Positive PROTECTIVE-2 Phase 3 Registrational Trial Results

In Clinical Trials by Barbara Jacoby

From: biospace.com BeyondSpring (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced the new data from its Phase 3 PROTECTIVE-2 Study 106 demonstrating that plinabulin in combination with pegfilgrastim offers greater protection against chemotherapy-induced neutropenia (CIN) than the standard of care, pegfilgrastim alone. The study not only met the …

View Post

Palbociclib Demonstrates Prolonged OS/PFS When Initiated in Metastatic Breast Cancer

In Clinical Trials by Barbara Jacoby

By: Tony Berberabe, MPH From: targetedonc.com Patients who received palbociclib and fulvestrant before chemotherapy for metastatic breast cancer had greater clinical benefit versus patients who received placebo and fulvestrant, according to an exploratory subgroup analysis of the phase 3 PALOMA-3 trial. Patients who received palbociclib (Ibrance) and fulvestrant before chemotherapy for metastatic breast cancer had greater clinical benefit versus patients …