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Which drug first? new study aims to optimize breast cancer treatment sequence

NCT ID NCT07162259

Disease control Sponsor: Yan Xue Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at the best order to give two powerful antibody-drug conjugates (ADCs) — T-DXd and SG — to people with a common type of advanced breast cancer (HR+/HER2-). After standard hormone therapy stops working, doctors are unsure which drug to use first. The study will enroll 40 adults and track how long each sequence controls the cancer, as well as side effects. The goal is to find a smarter, personalized treatment plan.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG)
What this could lead to
If successful, this could help doctors choose the best sequence of these two drugs to extend life and improve quality of life for patients with advanced breast cancer.
What could go wrong
This is a small, early-phase study with only 40 participants, so results may not apply to everyone. The drugs can cause serious side effects, and the best sequence may not be clearly better.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult patients ≥18 years old; 2. Histologically or cytologically confirmed HR+/HER2- (HER2 IHC 0/IHC 1+ or IHC 2+ with FISH-negative) locally advanced unresectable or metastatic breast cancer, as defined by ASCO/CAP guidelines; 3. Prior treatment with CDK4/6i combined with endocrine therapy, with radiologically confirmed disease progression; 4. Presence of evaluable lesions; 5. Received ≤2 lines of chemotherapy for advanced disease; 6. Adequate organ function and performance status (ECOG score ≤2); 7. Signed informed consent. Exclusion Criteria: 1. Previous treatment with topoisomerase 1 (TOP-1) inhibitor-based therapy; 2. Severe cardiac, hepatic, or renal dysfunction or other serious comorbidities; 3. History of moderate to severe interstitial lung disease (ILD) with concurrent pulmonary insufficiency; 4. Symptomatic brain metastases; 5. History of allergy to key components of the investigational ADC drugs (e.g., payload, antibody, or linker); 6. Patients with active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or a history of intestinal obstruction or gastrointestinal (GI) perforation; 7. Uncontrolled cardiovascular diseases (e.g., NYHA Class III/IV heart failure, myocardial infarction within 6 months); 8. Active infections (e.g., HIV, active HBV/HCV infection); 9. Pregnant or lactating women.

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Conditions

The condition(s) this trial relates to.

breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Xi'an International Medical Center Hospital

    Xi'an, China

More trials for these conditions

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