For Triple-Negative Breast Cancer Patients Without Immunotherapy Options, FDA Approval of Datroway Brings Hope By Helping Patients Live Longer

“This is a huge win for our metastatic triple-negative breast cancer patients. My hope is that this will allow more options for patients and replace our traditional chemotherapies that did not work as effectively in the past,” Dr. Matt Kurian, a medical oncologist at St. Elizabeth’s Yung Family Cancer Center, tells SurvivorNet.

The approval is based on results from the TROPION‑Breast02 Phase 3 trial, which showed that Datroway extended survival by about 5 months compared with standard chemotherapy.

Datroway is a type of targeted cancer treatment known as an antibody-drug conjugate. These drugs combine targeted therapy and chemotherapy.

“This is a meaningful step forward,” says Dr. Sarah Premji, Assistant Director of Breast Cancer Research at the Sarah Cannon Research Institute.

“We’re seeing longer time before the cancer worsens, longer overall survival, and better patient‑reported outcomes, improved physical functioning, less pain, and better overall quality of life. That’s a win,” she tells SurvivorNet.

Datroway Leads To Strong Responses

Datroway was already approved for breast cancer patients who have hormone receptor positive (HR+), HER2-negative (HER2-) metastatic breast cancer, which means the cancer cells have receptors for either estrogen and/or progesterone and do not over-express the HER2 protein. The new TNBC approval reflects the strength of the trial results.

“The totality of the evidence showed this drug is superior to standard chemotherapy,” Dr. Aditya Bardia, an oncologist at UCLA Health Jonsson Comprehensive Cancer Center, tells SurvivorNet.

The TROPION‑Breast02 study enrolled patients with previously untreated, locally recurrent, inoperable, or metastatic TNBC who were ineligible for immunotherapy. Participants were randomly assigned to Datroway, and given the cancer drug intravenously every three weeks, or to standard chemotherapy.

Among 644 patients treated between May 2022 and June 2024, the trial data revealed that:

• Progression-free survival, or the time before cancer began to progress, was 10.8 months with Datroway vs. 5.6 months with chemotherapy alone.
• Overall survival, or the average time that patients were still living, was 23.7 months with Datroway vs. 18.7 months with chemotherapy alone.

“The improvements in both progression‑free and overall survival — about five months — translate to a 43% reduction in the risk of disease progression or death,” says Dr. Eleonora Teplinsky, head of breast medical oncology at Valley Health System.

What This Means For Patients

“We now have strong data supporting the use of antibody‑drug conjugates, Datroway and Trodelvy, in the first‑line setting for metastatic TNBC patients who can’t receive immunotherapy,” Dr. Premji explains.

Antibody‑drug conjugates (ADC) work by pairing a highly targeted antibody with a cancer‑killing drug. Cancer cells are essentially linked to very powerful chemotherapies in a targeted way that will not harm nearby cells.

An ADC is built from three parts:

• A monoclonal antibody that finds the cancer cell
• A cytotoxic chemotherapy payload that kills it
• A chemical linker that binds the two together and controls when the payload is released.

Dr. Kurian says Datroway’s newly endorsed role by the National Comprehensive Cancer Network (NCCN) could meaningfully reshape first‑line care for a subset of metastatic triple‑negative breast cancer patients.

“Based on the updated NCCN guidelines, I expect Datroway to become a preferred first‑line option for metastatic triple‑negative breast cancer patients who aren’t eligible for immunotherapy alongside sacituzumab govitecan,” he explains.

“Both are strong agents with solid frontline efficacy, and while they share a TROP2 target, their payloads differ,” Dr. Kurian adds.

He believes that the next challenge will be its real-world application.

“We’re going to need more data on sequencing and how these drugs perform outside of trials, because community physicians now have two viable options — and that’s where the real decision‑making begins.”

Managing Side Effects

Dr. Kurian says this approval could be a major shift for practicing physicians, especially compared to the long‑standing standard of care.

“I think this will have a huge impact. Our traditional single‑agent or doublet chemotherapy hasn’t been very effective, and it comes with significant toxicities, some of them permanent,” he explains. “Because of that, many patients never even make it to second‑ or third‑line options, given how aggressive their disease is.”

He emphasized that the new approval “gives [physicians] more sustainable options and creates durable responses we simply haven’t seen before in a disease with so few effective treatments.”

Datroway can cause side effects. During clinical studies, the most commonly reported reactions included:

• Stomatitis (mouth sores)
• Nausea and vomiting
• Fatigue
• Low blood cell counts (e.g., leukocytes, neutrophils, lymphocytes)
• Changes in liver enzymes (ALT, AST)
• Hair loss (alopecia)
• Eye-related symptoms (dry eye, keratitis)

If you or a loved one starts this treatment, it’s important to be vigilant for any notable side effects and tell your healthcare team immediately if they become problematic, especially eye problems.

Dr. Teplinsky tells SurvivorNet, “With antibody drug conjugates and specifically with Datroway, one of the side effects that people worry about is eye toxicity. They are recommended to make sure they see an eye doctor as soon as they start Datroway, and then there’s appropriate follow-up every so often to check the eyes, and there are protective eye drops that patients need to use.”

Early intervention can make a big difference in how well side effects are managed.

She says it’s important to understand what the side effects are and to be prepared for them. “So there are side effects of nausea, for example, making sure you’re having nausea medications that you can take at home, and things like that,” she adds.

Dr. Teplinsky further explains that a steroid mouth rinse for stomatitis and special medicated eye drops for eye toxicity are available.

Dr. Premji and Dr. Teplinsky note how important this approval is, as it offers hope for a subset of breast cancer patients in desperate need of improved outcomes.

Looking ahead, Dr. Premji says Datroway’s approval reflects a broader shift in oncology toward truly personalized care.

“The field is moving toward more individualized treatment based on the biology of each patient’s disease. We’re continually searching for markers that can predict who will benefit most from specific therapies and for ways to bring those insights earlier in the disease course to improve outcomes,” Dr. Premji says.

“As we study more investigational agents, our focus remains on finding the right treatment for the right patient and deepening our understanding of breast cancer,” Dr. Premji continues.

Triple‑Negative Breast Cancer

Medical oncologist Dr. Julie Nangia explains that breast cancers are classified by three key biomarkers: estrogen receptor (ER), progesterone receptor (PR), and HER2. Triple‑negative breast cancers lack all three, which makes them more challenging to treat.

Since triple-negative breast cancer tumors don’t express hormone receptors or HER2, they don’t respond to hormone therapy or HER2‑targeted drugs like Herceptin. Hence, chemotherapy was the long-held backbone of treatment.

“Any triple‑negative cancer that’s over half a centimeter or involves the lymph nodes needs chemotherapy,” Dr. Nangia says.

“This typically includes two different types of chemotherapy, each given for about three months. One class is taxanes, and the other is anthracyclines.”

Chemotherapy given before surgery, also called neoadjuvant therapy, is often recommended to shrink the tumor and make surgery more effective.

WATCH: Undergoing Chemo During Triple-Negative Breast Cancer Treatment

In other cases, chemotherapy may be given after surgery (adjuvant therapy) if cancer cells remain or if doctors want to reduce the risk of recurrence (the cancer returning after treatment).

Treatment choices also depend on disease burden, meaning how extensive the cancer is and how sick a patient feels.

“If the disease burden isn’t too high — meaning a woman doesn’t have many symptoms — we can sometimes start with oral chemotherapy,” says medical oncologist Dr. Elizabeth Comen.

“After three months, we reassess: Has the disease burden decreased? If so, we continue that treatment as long as it’s working. Eventually, resistance can develop, and that’s when IV chemotherapy often becomes the next step.”

Questions To Ask Your Doctor

• Am I eligible to receive Datroway?
• Why do you think Datroway is the right option for me at this point in my treatment?
• Is the safety and tolerability of Datroway acceptable for long-term use?
• What are the most common side effects, and how can we manage them?
• How often and for how long will I need to take Datroway?

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