The patient, a 67-year-old grandmother of three from Monrovia, California, had always been diligent about getting annual mammograms. Year after year, happily, nothing was found. Until spring 2023, when doctors at City of Hope® detected a problem in her right breast. A biopsy confirmed cancer, requiring surgery.
A lumpectomy was scheduled for August, but in the meantime, genetic screening found the BRCA2 mutation, indicating a high probability of additional breast cancer as well as ovarian cancer. As a result, the patient, who requested anonymity, opted for a double mastectomy.
As a further precaution, the patient also now takes the medication anastrozole, a so-called aromatase inhibitor that lowers the body’s levels of estrogen, a primary fuel for tumors. Aromatase inhibitors, such as letrozole, anastrozole or exemestane, are prescribed as standard of care for postmenopausal women with estrogen-receptor positive breast cancer to decrease breast cancer recurrence and mortality. Studies have shown that aromatase inhibitors do a better job at preventing cancer recurrence than tamoxifen, an older therapy once considered the treatment of choice.
But trouble developed after just 10 months.
“I had severe pain in my ankle and heel,” she recalled. Turns out, nearly half the women who take aromatase inhibitors develop significant joint pain. For some, the pain is so severe they stop taking the medication, putting their lives at risk. The patient almost did the same, cutting her dosage in half, taking it every other day instead of daily. She felt frustrated. “This was affecting my quality of life. It’s not acceptable that I couldn’t walk without pain.”
Could BRC-001 Ease Cancer Pain?
But hope emerged in the form of a City of Hope clinical trial testing BRC-001, a pharmaceutical grade cannabis-derived product that may alleviate her pain.
The source of this product is from the same plant species as cannabis, but with almost none of the tetrahydrocannabinol (THC) that causes the mind-altering “high” of marijuana. What it does contain is a significant amount of cannabidiol, or CBD, a substance used by many people for a variety of ailments, from chronic pain to inflammation to insomnia. Uniquely formulated, BRC-001 also contains other cannabinoids in proprietary, targeted ratios designed to safely and effectively treat aromatase inhibitor-induced joint pain.
This trial likely would not have happened less than a decade ago. While cannabis research remains illegal at the federal level, unless performed under restrictive research regimes, the Farm Act of 2018 relaxed the regulations on items containing less than 0.3% THC. BRC-001, described as a “high cannabidiol botanical extract,” qualifies.
This is a new direction for City of Hope researchers, and it wasn’t approached lightly. While some other institutions have taken tentative steps into the cannabis-based medicine arena, City of Hope has not been among them. Until now.
“For a long time,” explained Yuman Fong, M.D., Sangiacomo Family Chair in Surgical Oncology and a key figure in initiating the study, “City of Hope wasn’t interested in cannabis [products]. But now we see them as real medicine, and we’re going to put them through the most rigorous testing.”
It’s that meticulous testing that’s key.
Cannabis-derived products have been around for years, and a considerable amount of anecdotal and other data have grown up around the field. But before the Food and Drug Administration Administration (FDA) can approve any drug — and insurance companies pay for it — strict protocols must be followed, from consistency and exactitude in measuring each ingredient to the clinical trials process, examining safety and efficacy. So far only one cannabis-derived drug has successfully gone through that process: Epidiolex®, FDA-approved in 2018 to treat epileptic seizures in children.
'Women who had a vital life suddenly can’t move. So, if there’s an answer that’s safe and non-narcotic, I’m all for it.'
Lisa Yee, M.D., breast cancer surgeon
BRC-001 was developed by the Monterey, California-based Biopharmaceutical Research Company. The company creates pharmaceutical grade cannabis-based medicines to help patients with serious medical conditions. It operates out of a high-security facility that is continuously monitored to comply with the requirements of the FDA and the Drug Enforcement Administration.
Dr. Fong brought BRC-001 to City of Hope’s attention after discussions with fellow surgeons revealed a need for better, non-opioid ways to treat pain. One of those surgeons, Lisa Yee, M.D., is now the lead investigator for the study. Specializing in breast cancer, Dr. Yee has spent decades examining a variety of treatments such as omega-3 and other so-called nutraceuticals. And she was all too familiar with the unique joint pain problem among her patients taking aromatase inhibitors. Some of them, she said, were simply “desperate” for a better way.
“The pain caused by aromatase inhibitors is very vexing,” said Dr. Yee, professor in the Division of Breast Surgery, Department of Surgery. “Women who had a vital life suddenly can’t move. So, if there’s an answer that’s safe and non-narcotic, I’m all for it.”
Dr. Yee is being aided by a pilot grant from City of Hope’s Cherng Family Center for Integrative Oncology, a new national program that brings together Eastern and Western medicine to improve outcomes and quality of life for patients and survivors. Launched one year ago with a gift from Andrew and Peggy Cherng, the Center aims to make integrative oncology an evidence-based, interwoven standard of care that supports optimal cancer treatment and survivorship.
“This is the type of study we’ve been hoping to do,” said Richard T. Lee, M.D., Cherng Family Director's Chair of the Center for Integrative Oncology. “There’s this huge gap. Patients have been using CBD, but there’s been no good science, no real studies to support it. Yes, this is a bit of a leap, but City of Hope always wants to be the pioneer, using the framework of research. As long as there’s a strong research approach, City of Hope is open to it.”
Cannabinoid-Based Drug Trial Enters Phase 2
Forty women will participate in the current double-blind trial, which is now in Phase 2, testing for effectiveness and side effects. Half the patients will receive BRC-001; the others will be given a placebo. The 67-year-old grandmother was the first to join the trial.
It’s not clear why CBD medications seem to work, but Dr. Yee has some theories. “They may have anti-inflammatory properties,” she suggests. “They may interact with the body’s endocannabinoid system” — a complex network of receptors affecting many bodily functions. “Or they may alter one’s perception of pain.”
Whatever the mechanism, Dr. Yee can’t wait to find out.
“There’s a lot of interest in this,” she said. “My oncology colleagues from other institutions keep asking me about it. We hope we’re breaking down some barriers. People still think, ‘This is marijuana.’ It’s not. It’s a vetted drug.
“We’re excited. And we’re just getting started.”