monarchE clinical trial
BCNA is working to ensure that Australians diagnosed with breast cancer have access to clinical trials that may benefit them.
The CDK inhibitors are a new class of drugs that have been shown in clinical trials to slow down the progress of disease for people with hormone positive, HER2-negative metastatic breast cancer. A new clinical trial, monarchE, is now looking at whether the CDKs might also help people diagnosed with high risk hormone-positive, HER2-negative early breast cancer. This trial is important as it will provide information about the potential usefulness of the CDK inhibitors for Australian diagnosed with early breast cancer.
We asked BCNA member Marisa, a current participant in the monarchE clinical trial, to share her experience with us:
Researchers are aware of the positive results of the drug Abemaciclib with stage 3 and 4 breast cancer. It is therefore important to see how it may enhance the post-surgical Femara endocrine therapy as well – hence the importance of the trial. I was pleased to participate even though there were a few rocky moments. There were [some] unpleasant side effects. But the support network at [the hospital] was reassuring and helpful. With a dosage adjustment I soon felt 'normal' again.
– Marisa, participant in the monarchE clinical trial
The randomised Phase III clinical trial monarchE: Endocrine Therapy With or Without Abemaciclib Following Surgery in Participants with Breast Cancer is comparing the effectiveness of treatment with standard hormone blocking therapy in combination with the CDK inhibitor abemaciclb to hormone-blocking therapy alone in people diagnosed with high risk, hormone-positive, HER2-negative early breast cancer.
This clinical trial is open to women and men. It is currently recruiting at a number of hospitals in Australia, including hospitals in New South Wales, Queensland, South Australia, Tasmania, Victoria and Western Australia.
You may be eligible for the monarchE clinical trial if:
- you have been diagnosed with high risk hormone-positive, HER2-negative early breast cancer where the cancer has spread to 4 or more lymph nodes, is bigger than 5 cm or classified as Grade 3.
You must also have had breast surgery and be able to join the trial within 16 months of having breast surgery and have completed no more than 12 weeks of hormone therapy.
If you have had chemotherapy before surgery, the trial might also be suitable for you if there was residual cancer found.
Your oncologist will be able to provide further details on eligibility.
More information, including which Australian hospitals are running the trial, is available on the ClinicalTrials.gov.