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Sacituzumab Govitecan Therapy - Trodelvy
Medical Oncology

Sacituzumab Govitecan Therapy - Trodelvy

About This Department

 
Medical oncology

Chemotherapy strong enough to kill a cancer cell harms the rest of the body too. Trodelvy attaches it to an antibody that carries it to the tumor.

Sacituzumab govitecan, sold as Trodelvy, is an antibody-drug conjugate. An antibody that seeks out TROP-2, a protein on the surface of most breast cancer cells, carries a potent chemotherapy called SN-38 to the tumor and releases it there and in the cells around it. It is given as a drip on days 1 and 8 of every three-week cycle. In triple-negative breast cancer that had come back after at least two earlier treatments, it nearly doubled median survival, 12.1 months against 6.7 months on standard chemotherapy (Bardia and colleagues, New England Journal of Medicine, 2021). In hormone receptor-positive breast cancer after hormone therapy and chemotherapy, it extended survival as well (Rugo and colleagues, Lancet, 2023), and in June 2026 it was approved in the United States as a first treatment for triple-negative breast cancer that has spread, alone or with pembrolizumab. This page explains how the drug works, who can receive it, the trial results, how it compares with trastuzumab deruxtecan, what a treatment day looks like, the side effects and how they are prevented, and how patients from abroad arrange treatment at Biruni Hospital in Istanbul.

12.1
Months median survival with sacituzumab govitecan in pretreated triple-negative breast cancer, against 6.7 months on chemotherapy
35
Percent of patients whose tumors shrank substantially on the drug, against 5 percent on chemotherapy
14.4
Months median survival in hormone receptor-positive breast cancer, against 11.2 months on chemotherapy
Free
Review of your pathology report and scans by the medical oncology team
Free consultation

What Trodelvy is

Ordinary chemotherapy travels everywhere the blood goes. An antibody-drug conjugate works like a guided parcel. The antibody finds a marker on cancer cells, the cell swallows it, and the chemotherapy it carries is set free inside. Trodelvy goes one step further. Its linker also releases part of the drug just outside the cell, so neighboring cancer cells without the marker are hit as well, an effect called bystander killing.

Three parts

How sacituzumab govitecan is built
Part What it is What it does
Antibody Sacituzumab, aimed at TROP-2 Finds cancer cells that carry TROP-2 on their surface
Linker A chemical bridge that breaks down slowly Releases the drug inside the cell and in the tissue around it
Payload SN-38, the active form of irinotecan Blocks topoisomerase I, an enzyme the cell needs to copy its DNA
Sacituzumab govitecan is an antibody-drug conjugate composed of an antibody targeting the human trophoblast cell-surface antigen 2 (Trop-2), which is expressed in the majority of breast cancers, coupled to SN-38 through a proprietary hydrolyzable linker (Bardia and colleagues, 2021).
Trodelvy at a glance
Item Detail Note
Dose 10 milligrams per kilogram of body weight Lowered in steps if side effects require it
Schedule Days 1 and 8 of each 21-day cycle Continued while it works and is tolerated
Infusion time Three hours the first time, one to two hours after 30 minutes of observation after each drip

Who can receive it

TROP-2 is present on nearly all breast cancers, so no TROP-2 test is required before treatment. In TROPiCS-02, the survival benefit was consistent across levels of TROP-2 expression.
Do I need a special test first?
No marker test is required. What decides eligibility is the type of breast cancer, set out in the pathology report as estrogen receptor, progesterone receptor and HER2 status, the treatments already given and, for the first-line combination with pembrolizumab, the PD-L1 score. A blood test for a gene called UGT1A1 is useful though optional. Patients who carry two copies of the slower variant, UGT1A1*28, clear SN-38 more slowly and face a higher risk of a low white cell count.
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What the oncologist checks
Blood counts, liver and kidney function, general fitness, any bowel disease that would make diarrhea dangerous, and the list of current medicines, since some drugs slow the breakdown of SN-38.
Patients whose cancer has spread to the brain can still be treated when the brain disease is stable. The large trial excluded active brain metastases, so the decision is made case by case with the radiation oncologist.

Triple-negative, after earlier treatment

ASCENT trial results
Measure Sacituzumab govitecan Chemotherapy of choice
Median time before growth 5.6 months 1.7 months
Median survival 12.1 months 6.7 months
Tumor shrinkage 35 percent 5 percent
Progression-free and overall survival were significantly longer with sacituzumab govitecan than with single-agent chemotherapy among patients with metastatic triple-negative breast cancer. Myelosuppression and diarrhea were more frequent with sacituzumab govitecan (Bardia and colleagues, 2021).
ASCENT enrolled 468 patients without brain metastases whose triple-negative breast cancer had progressed after at least two chemotherapy regimens for advanced disease, one of which could be treatment given before or after surgery if the cancer came back within twelve months. All had received a taxane. The comparison was eribulin, vinorelbine, capecitabine or gemcitabine, the drugs such patients would otherwise receive. The median age was 54.
The approved use after earlier treatment
Requirement Detail Why
Cancer type Triple-negative, locally advanced or spread The trial population
Earlier treatment Two or more systemic treatments, at least one for advanced disease Mirrors the trial entry rule
Fitness Able to manage daily life with little help Needed to tolerate the drug

Triple-negative, as the first treatment

First-line trials approved in June 2026
Trial Patients Median time before growth
ASCENT-03, Trodelvy alone 558 patients who could not receive immunotherapy 9.7 months against 6.9 on chemotherapy
ASCENT-04, Trodelvy with pembrolizumab 443 patients with PD-L1 CPS of 10 or more 11.2 months against 7.8 on chemotherapy with pembrolizumab
On 24 June 2026 the United States Food and Drug Administration approved sacituzumab govitecan for triple-negative breast cancer that has spread or cannot be removed, as the first treatment. Alone for patients who cannot receive a PD-1 or PD-L1 immunotherapy drug, and together with pembrolizumab when the tumor expresses PD-L1 with a combined positive score of 10 or more. Approvals in Europe and elsewhere follow their own timelines, and the team confirms availability for each patient before planning.
Choosing the first treatment for spread triple-negative cancer
Situation First choice Note
PD-L1 CPS 10 or more Trodelvy with pembrolizumab Or chemotherapy with pembrolizumab
PD-L1 below 10, or immunotherapy not possible Trodelvy alone Or chemotherapy
Inherited BRCA mutation A PARP inhibitor is also an option Olaparib or talazoparib
Relapse soon after pembrolizumab before surgery Discussed at the tumor board Immunotherapy may not be repeated
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Same drug, earlier
Using the drug first means it acts on a cancer that has not yet been weakened by years of treatment, and on a patient in better condition. Responses in ASCENT-04 reached 61 percent.

Hormone receptor-positive cancer

Overall survival was significantly improved with sacituzumab govitecan versus chemotherapy (median 14.4 months vs 11.2 months), and the survival benefit was consistent across Trop-2 expression-level subgroups (Rugo and colleagues, 2023).
1
Who it suits
Women and men with hormone receptor-positive, HER2-negative breast cancer that has spread and that no longer responds to hormone therapy, after a CDK4/6 inhibitor, and after at least two chemotherapy regimens for advanced disease.
The TROPiCS-02 patients had been heavily treated, with a median of three earlier chemotherapies. A gain of 3.2 months in median survival in that setting is meaningful, and quality of life held up longer on the drug than on chemotherapy. Fatigue worsened later too.
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Where it fits in the sequence
Hormone therapy with a CDK4/6 inhibitor comes first, then further hormone-based options guided by gene tests such as ESR1 and PIK3CA, then chemotherapy or an antibody-drug conjugate.
Antibody-drug conjugates in hormone receptor-positive cancer
Drug Target When it is used
Trastuzumab deruxtecan, Enhertu HER2, including HER2-low and ultralow After hormone therapy, before or after chemotherapy
Sacituzumab govitecan, Trodelvy TROP-2 After hormone therapy and two chemotherapy regimens
Datopotamab deruxtecan, Datroway TROP-2 After hormone therapy and one chemotherapy regimen
Most patients with HER2-low disease receive trastuzumab deruxtecan first, and Trodelvy follows.

Who benefits most

Fit patients do best.

In the subgroup analyses of ASCENT and TROPiCS-02, the drug helped across ages, across levels of TROP-2 and regardless of how many treatments had come before, but the patients who got the most out of it were those still able to lead an active life when they started. A patient confined to bed by the cancer has less reserve to handle a low white cell count or three weeks of diarrhea, and the oncologist weighs that before the first dose. Timing matters too. The drug works better the earlier it is used, and the 2026 first-line approval reflects that. Two groups need more care. Patients with liver function tests well above normal were excluded from the trials, and those who carry two copies of UGT1A1*28 start with a closer watch on blood counts.

Trodelvy or Enhertu

Comparing the two most used antibody-drug conjugates in breast cancer
Feature Trodelvy Enhertu
Target TROP-2 HER2
Payload SN-38, a topoisomerase I blocker Deruxtecan, also a topoisomerase I blocker
Schedule Days 1 and 8 every three weeks Once every three weeks
Main risks Low white cells, diarrhea Nausea, lung inflammation
Needs a marker No HER2 positive, low or ultralow
Which should come first, and does the second one still work?
When the tumor is HER2-positive or HER2-low, trastuzumab deruxtecan usually comes first. Both drugs carry the same class of chemotherapy, and responses to the second are lower than to the first, since the cancer may have learned to resist that payload. Studies that gave one after the other found tumor shrinkage in only a minority of patients on the second drug, and that benefit lasted a shorter time. The oncologist plans the order from the very first line of treatment, keeping the second drug in reserve for when the first stops working.
Two antibody-drug conjugates now sit side by side in breast cancer care. The order matters, and the tumor board sets it.

A treatment day

1
Day 1 and day 8
Blood count checked the same morning. Premedicines 30 minutes before, a fever reducer, antihistamines and two or three anti-sickness drugs. Then the drip, three hours the first time, one to two hours after, and half an hour of observation. Home by the afternoon, with anti-sickness tablets and loperamide.
Each cycle lasts three weeks. Day 8 goes ahead only if the neutrophil count is high enough, and if it is not, the dose is delayed a week. Scans every two to three cycles measure response. Many centers now give a growth factor injection after each dose to protect the white cell count, which lowers the chance of fever and infection.

Side effects

The drug carries a boxed warning in the United States for two effects, a low white cell count and severe diarrhea. Both are expected, both are watched for, and both are prevented where possible.
  • Low white cells, grade 3 or worse in half of patients in ASCENT, and fever with infection in 6 percent.
  • Diarrhea, severe in 10 percent, managed with loperamide from the first loose stool.
  • Nausea, vomiting, tiredness and hair loss, the last in close to half of patients.
Common side effects and what helps
Side effect How often What helps
Low white cells Grade 3 or worse in about half Growth factor injections, dose delay, a call at any fever of 38 degrees
Diarrhea Two thirds, severe in one in ten Loperamide early, fluids, a call if more than four extra stools a day
Nausea Around six in ten Two or three anti-sickness drugs before each dose
Hair loss Close to half Regrows after treatment ends
Anemia Severe in 8 percent Iron checks, transfusion if needed
The incidences of key treatment-related adverse events of grade 3 or higher were neutropenia (51 percent with sacituzumab govitecan and 33 percent with chemotherapy), diarrhea (10 percent and less than 1 percent) and febrile neutropenia (6 percent and 2 percent) (Bardia and colleagues, 2021).
Early diarrhea and late diarrhea
Type When Treatment
Early, from the nerve effect of SN-38 During or within hours of the drip, with cramps, sweating and watering eyes An atropine injection in the unit
Late Days after the dose Loperamide, fluids and, if severe, a pause and a lower dose

Other cancers

TROP-2 sits on many solid tumors, and the drug has been tested widely. The results outside breast cancer have been mixed. The United States approval for bladder cancer, granted early on the basis of response rates, was withdrawn in 2024 after the confirmatory trial did not show longer survival. In lung cancer, the EVOKE-01 trial against docetaxel also missed its survival goal.
Sacituzumab govitecan outside breast cancer
Cancer Status Note
Bladder and urinary tract cancer Approval withdrawn in the United States in 2024 Responses in 27 percent in the earlier TROPHY-U-01 study
Non-small cell lung cancer Not approved Combination trials with immunotherapy continue
Womb, stomach, head and neck and other cancers Clinical trials Available only within a study

Life between infusions

The week after each dose is the hardest.

Tiredness and loose stools peak in the days after day 1 and day 8, then ease in the third week. Plan around it. Keep a thermometer at home and check it whenever you feel unwell. Drink more than usual, avoid undercooked meat, eggs and unwashed salad while the white cell count is low, and wash hands before every meal. Grapefruit juice is avoided, and every new medicine, including herbal ones, is checked with the oncology pharmacist first. Pregnancy has to be avoided during treatment and for six months after the last dose in women, and for three months in men. A cold cap reduces hair loss for some patients.

Treatment for patients from abroad

One coordinator from the international patients office handles arrangements from the first message through discharge and answers the same WhatsApp number once you are back home. The office works in English, Arabic, French, Russian, Serbian, Romanian and Spanish and books interpreters for other languages, and it arranges the visa invitation letter, airport transfers, daily transport and accommodation near the hospital. Halal, vegetarian and diabetic meals, a prayer room on site, and a female physician on request wherever the rota allows.
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Length of stay and fitness to fly
A first stay of about three weeks covers the consultation, tests, the first full cycle and the white cell count low point that follows. Patients are fit to fly once the count has recovered and diarrhea is under control.
Because the drug is given twice every three weeks, patients from abroad choose between two plans. Some stay in Istanbul for several cycles, in an apartment near the hospital, with scans here after every second or third cycle. Others complete the first cycle here, then continue with an oncologist at home who follows the plan and doses we send, and return for scans and review. Before the first visit we need the pathology report with hormone receptor, HER2 and, where relevant, PD-L1 results, recent scans as image files, and a summary of every treatment so far.

Cost

The price depends on body weight, since the dose is calculated per kilogram, and on the number of cycles. Trodelvy is among the more expensive cancer drugs, and a full course runs for as long as it controls the disease. Quotes are given per cycle.

What the quote covers

What a quote for Trodelvy covers
Item Included Priced separately
The drug Two doses per three-week cycle Pembrolizumab when given with it
Treatment day Consultation, blood count, premedicines, day unit chair Admission for fever or diarrhea
Support Anti-sickness medicines, loperamide Growth factor injections, scans, UGT1A1 test

Comparing quotes

Request from each center the price of the same number of cycles at your weight, and whether premedicines, growth factor injections and blood tests are included.

References

  1. Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med. 2021;384(16):1529-1541.
  2. Rugo HS, Bardia A, Marmé F, et al. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02). A randomised, open-label, multicentre, phase 3 trial. Lancet. 2023;402(10411):1423-1433.
  3. Bardia A, Mayer IA, Vahdat LT, et al. Sacituzumab govitecan-hziy in refractory metastatic triple-negative breast cancer. N Engl J Med. 2019;380(8):741-751.
  4. Tagawa ST, Balar AV, Petrylak DP, et al. TROPHY-U-01. A phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors. J Clin Oncol. 2021;39(22):2474-2485.

Editor's note

Written by the Biruni Hospital medical editorial team. Reviewed by Prof. Dr. Özcan YILDIZ, Medical Oncology.

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