MONALEESA-7 is the first prospective global phase III trial in more than 20 years, designed specifically for premenopausal women diagnosed with advanced breast cancer, to demonstrate superiority of any CDK4/6 inhibitor in combination with oral hormonal therapies and goserelin versus endocrine treatment alone in this patient population.
The trial included 3,270 patients with early-stage breast cancer.
Novartis is looking for an expanded combination therapy label for its Kisqali after a trial showed it halts progression of an aggressive kind of breast cancer in younger women for longer than standard drugs. The improvement in mean BPI "worst pain" score for those receiving true acupuncture remained significant compared to the other two group's scores over 24 weeks.
There were no new safety signals and adverse events were consistent with those in the previous MONALEESA-2 study.
These drugs - which include Arimidex, Femara and Aromasin, among others - are often used to treat women with estrogen-sensitive breast tumors, Hershman said. Fehrenbacher presented results of the NASBP-B-47 trial at the 2017 San Antonio Breast Cancer Symposium (SABCS), held December 5-9. "We need to identify strategies to control these side effects, the most common of which is debilitating joint pain and stiffness".
Data from the study showed that on average, patients who received true acupuncture reported experiencing less pain and stiffness - even after they stopped receiving acupuncture.
For more from Rare Disease Report, follow along on Facebook and Twitter. After six weeks, patients in the true acupuncture treatment group reported significantly lower BPI "worst pain" by almost a point compared with those receiving sham acupuncture and no acupuncture. Reading over the findings, she agreed that "the integration of Western and Eastern medicine is an important path to explore" in breast cancer care.
"This is yet another study that reveals the benefits of acupuncture in treating pain", Coomer said.