LiveWell mBC is a group-based skills training program for women with metastatic breast cancer (mBC). The program teaches skills from dialectical behavioral therapy, an evidence-based psychotherapy, that have been adapted specifically to help women live as well as possible, with metastatic breast cancer. LiveWell mBC involves meeting with a small group of women with mBC plus two skills trainers 9 times total via telemedicine. Meetings include orientation plus 8 sessions learning and practicing skills including mindfulness, emotion regulation, distress tolerance and interpersonal effectiveness and they last 90 minutes each. We are interested in seeing whether the program can help women to balance their emotions and better manage distress (e.g., anxiety, sadness) and symptoms (e.g., fatigue, breathlessness, pain) that can be common when living with mBC.

Participants will be randomly assigned to one of two groups. They will have a 2 in 3 chance of being assigned to LiveWell mBC (experimental group) and a 1 in 3 chance of being assigned to Usual Care (control group). Women in the usual care group will continue to receive their standard oncology care. Participants in both groups will complete questionnaires four times total. Participants may be invited to participate in an exit interview about their experience. Participants will be compensated for completing questionnaires and the interview. For most people, participation will last approximately 4 months.

The purpose of this study is to learn more about long-term safety (good or bad effects) of avacopan and its efficacy (how well it is working) in treatment of antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis.

Avacopan is currently approved as an adjunctive (another treatment used along with primary treatment) treatment in adult people with severe active ANCA-associated vasculitis in the US and is also approved in the EU, Canada, Japan, and other countries.

In this study, avacopan will be compared with a placebo (a drug that looks likes the study medication but does not contain any medication). This is a randomized study, meaning that you will be assigned by chance (like flipping a coin) into a treatment group. You will have an equal chance of being placed in either of the 3 following groups: treatment with avacopan for 5 years in group A, or treatment with avacopan for 1 year followed by placebo for 4 years in group B, or treatment with placebo for 5 years in group C. The study is also a double-blinded study, meaning you and your study doctor will not know what you are receiving, the avacopan or placebo.

The study is sponsored by Amgen, Inc. Participation in the study will require 27 visits to the MUSC main campus over approximately 63 months, and visits will include the following procedures: blood draw, urine collection, physician-led assessments of your disease (for example physical exam and medical history review), and health questionnaires. You will also be provided with a paper diary to record any missed doses/overdoses of the study drug.

Compensation is available for participation.