A new breast cancer treatment earns FDA approval—and may allow patients to skip chemo, radiation, and surgery
Industry Buzz
Those little frozen cells—we’ve killed the cancer in the DNA. We’re saving you a general anesthetic, we’re saving you the chance of infection or a really hideous scar.
—Belinda Barclay-White, MD
Patients with breast cancer have come to expect a certain treatment protocol: surgery, radiation, and/or systemic therapy.
But the FDA has just granted marketing authorization for a new kind of treatment outside the familiar trio: cryoablation as a primary treatment for early stage, low-risk breast cancer in women aged 70 or older.[][]
The ProSense Cryoablation System uses extreme cold to destroy tumor cells. For eligible patients, it offers what many never thought possible: cancer removal without the OR, general anesthesia, and the scarring and recovery associated with lumpectomy.
“I was doing a happy dance … I’m just … grateful,” 81-year-old Carolyn Purcell, who underwent the procedure in 2016 as part of a clinical trial, told Arizona’s Family.[]
How it works—and why it’s now approved
Belinda Barclay-White, MD, who has treated more than 150 patients in trials, describes the technology simply: “Those little frozen cells, we’ve killed the cancer in the DNA We’re saving you a general anesthetic, we’re saving you the chance of infection or a really hideous scar."[]
The procedure is performed in a clinic setting. It takes about the same amount of time and is the same level of invasiveness as a diagnostic core biopsy.
The typical patient goes home the same day and may consider themselves cancer-free almost immediately, assuming vigilant follow-up imaging confirms complete ablation.
Who benefits most right now
Patients 70 or older with:
Early stage, low-grade, ER+ disease
Tumors typically ≤ 1.5 cm
No suspicious lymph nodes
For this cohort, avoiding general anesthesia, surgical complications, and radiation toxicities can significantly improve quality of life.
Why screening still matters
Purcell’s sister, diagnosed in the same year, missed a mammogram and presented with stage III disease—requiring standard multimodal therapy. Their parallel but divergent paths reinforce the same reminder:
“That’s the reward for screening,” Dr. Barclay-White said. “Let’s find it early and then we can offer you this [new treatment].”
What comes next?
With FDA approval now secured, researchers aim to expand eligibility in future studies that will investigate efficacy in younger patients and more aggressive tumor biology. Key questions remain:
Can cryoablation safely replace lumpectomy in broader populations?
How do local recurrence rates compare in the long term?
What is optimal imaging and endocrine management plan following ablation?
You may want to consider cryoablation when counseling older patients with very low-risk tumors who may be reluctant to pursue surgery or radiation. And in some of your patients, if you're comfortable de-escalating therapy to lumpectomy alone, cryoablation may be a viable alternative.
The FDA approval signals a broader shift in breast cancer: matching treatment intensity to tumor biology and patient priorities, not tradition.
Related: Why women of color may respond differently to breast cancer treatments