FDA Grants Breakthrough Therapy Designation to DS-8201 for HER-2-Positive Breast Cancer

Excerpt:

“The FDA granted breakthrough therapy designation to DS-8201 for the treatment of HER-2-positive locally advanced or metastatic breast cancer that progressed after treatment with other HER-2-targeting agents.

“The agency based the designation on preliminary evidence from a phase 1 study designed to evaluate the safety, tolerability and efficacy of DS-8201 (Daiichi Sankyo), an investigational HER-2-targeting antibody-drug conjugate.”

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Fulvestrant Gains New Breast Cancer Indication

Excerpt:

“The FDA expanded the indications for fulvestrant (Faslodex) to include use as first-line monotherapy in postmenopausal women with estrogen receptor-positive, HER-2 negative breast cancer, drugmaker AstraZeneca said Monday.

“Previously the drug was approved as second-line monotherapy for women failing anti-estrogen therapy, and as second-line combination therapy with palbociclib (Ibrance). It was first approved by the FDA in 2002.”

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Julie Rubidge – One Deloitte Patient’s Story


Julie Rubidge

As one might imagine, Julie Rubidge’s diagnosis in May 2016 of an aggressive form of breast cancer at age 39 was shocking and surprising. The first few weeks that followed were no less traumatic for the Deloitte Partner. “I cannot adequately describe the weeks that followed in trying to figure out a plan of action and everything that goes along with that. It was overwhelming to say the least,” Julie says.

Detail-oriented and fascinated with medicine, specifically with DNA and the technology behind medicine and medical discoveries, Julie has called her interest in the subject one of her hobbies. Before her diagnosis, she’d read many articles and had studied the subject in general. Following her diagnosis, Julie studied her particular breast cancer with a fierce purpose. Continue reading…


AKT Inhibitor Ipatasertib in Metastatic Triple-Negative Breast Cancer

Excerpt:

“The randomized phase II LOTUS trial has shown improved progression-free survival with the addition of the AKT inhibitor ipatasertib to paclitaxel in the first-line treatment of metastatic triple-negative breast cancer. These results were reported by Kim et al in The Lancet Oncology. The PI3K/AKT signaling pathway is frequently activated in triple-negative breast cancer.

“In the double-blind trial, 124 patients with unresectable locally advanced or metastatic disease from 44 sites in South Korea, the United States, France, Spain, Taiwan, Singapore, Italy, and Belgium were randomized between September 2014 and February 2016 to receive paclitaxel at 80 mg/m² on days 1, 8, and 15 with either ipatasertib at 400 mg (n = 62) or placebo (n = 62) once daily on days 1 to 21 every 28 days until disease progression or unacceptable toxicity. Stratification factors included tumor PTEN status as determined by immunohistochemistry; deficient expression of PTEN is associated with greater AKT pathway activation. The co-primary endpoints were progression-free survival in the intention-to-treat population and progression-free survival in the PTEN-low population.”

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How Decision-Making Habits Influence the Breast Cancer Treatments Women Consider

Excerpt:

“A new study finds that more than half of women with early stage breast cancer considered an aggressive type of surgery to remove both breasts. The way women generally approach big decisions, combined with their values, impacts what breast cancer treatment they consider, the study also found.

“Contralateral prophylactic  – a procedure to remove both breasts when  occurs in only one breast – has become increasingly popular in recent years, with more than 20 percent of  opting for it. For most women, removing the unaffected breast does not improve survival.”

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A Cancer Conundrum: Too Many Drug Trials, Too Few Patients

Excerpt:

“With the arrival of two revolutionary treatment strategies, immunotherapy and personalized medicine, cancer researchers have found new hope — and a problem that is perhaps unprecedented in medical research.

“There are too many experimental cancer drugs in too many clinical trials, and not enough patients to test them on.

“The logjam is caused partly by companies hoping to rush profitable new cancer drugs to market, and partly by the nature of these therapies, which can be spectacularly effective but only in select patients.”

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Sacituzumab Govitecan Demonstrates Durable Responses in Metastatic TNBC

Excerpt:

“Sacituzumab govitecan (IMMU-132) was well tolerated and demonstrated early and durable responses in heavily pretreated patients with metastatic triple-negative breast cancer (mTNBC), according to the results of a recent phase I/II study published in the Journal of Clinical Oncology.

“Sacituzumab govitecan is an antibody–drug conjugate that targets Trop-2, which is expressed in more than 90% of TNBCs, by selectively delivering SN-38, the active metabolite of irinotecan. It was granted a breakthrough therapy designation by the FDA in February 2016 for the treatment of patients with mTNBC, following at least 2 treatments for metastatic disease.”

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Neoadjuvant T-DM1 Improves pCR in HER2+/HR+ Early Breast Cancer

Excerpt:

“Twelve weeks of neoadjuvant T-DM1 (ado-trastuzumab emtansine; Kadcyla) with or without endocrine therapy induced superior pathologic complete response (pCR) compared with trastuzumab (Herceptin) plus endocrine therapy in patients with HER2-positive/HR-positive early breast cancer, according to findings recently published online in theJournal of Clinical Oncology.

“In the prospective, neoadjuvant phase II ADAPT trial conducted by the West German Study Group, pCR was 41.0% for patients assigned to T-DM1 alone and 41.5% for those who received T-DM1 and endocrine therapy. In contrast, 15.1% of patients assigned to trastuzumab and endocrine therapy had a pCR (P<.001).”

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Young Breast Cancer Patients Undergoing Breast Conserving Surgery See Improved Prognosis

Excerpt:

“A new analysis indicates that breast cancer prognoses have improved over time in young women treated with breast conserving surgery. The analysis included 1331 patients younger than 40 years treated with breast conserving surgery and whole breast radiotherapy in a single cancer centre in Italy between 1997 and 2010.

“Breast cancer recurrences and deaths significantly decreased over time. A dramatic improvement in prognosis was observed after 2005, when the use of several new diagnostic and  were implemented in routine clinical practice.”

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