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Triple-Drug cocktail aims to stall aggressive breast cancer

NCT ID NCT04537286

Disease control Sponsor: Fudan University 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether a combination of two chemotherapy drugs (nab-paclitaxel and cisplatin) plus an immunotherapy drug (camrelizumab) can help people with metastatic triple-negative breast cancer live longer without their disease getting worse. The study enrolls women aged 18 to 70 who have not received prior treatment for metastatic disease. Researchers are tracking how long the cancer stays under control and what side effects occur.

What this could mean

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

Active substance
a combination of nab-paclitaxel, cisplatin, and camrelizumab
What this could lead to
If successful, this combination could become a new first-line treatment option for people with metastatic triple-negative breast cancer, potentially improving how long the disease is kept under control.
What could go wrong
This is a small, single-arm phase 2 study, so results may not be confirmed in larger trials. The three-drug combination may also cause more side effects than standard treatments.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

90 people

The number who actually took part.

Started

Aug 2020

Finished

Jul 2024

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 70 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. Female patients aged 18-70 years who had 2. Metastatic TNBC. ER, PgR, and HER2 status were determined locally by immunohistochemistry (IHC) of patient primary or metastatic tumor sections. Metastatic disease was confirmed by clinical, imaging, histological or cytological measures. 3. Patients were required to receive no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer. 4. Patients who had received adjuvant/neoadjuvant therapy were required an interval for at least 6 months after stop of chemotherapy before the enrollment. 5. At least one measurable lesion according to RECIST 1.1, 6. ECOG performance status ≤ 1 7. Life expectancy of more than 12 weeks 8. Adequate organ and bone marrow function. Exclusion Criteria: 1. Patient of childbearing potential but unwilling to receive contraception. 2. Radiation therapy of axial bone within 4 weeks before enrollment. 3. Previous treatment with PD-1 antibody, PD-L1 antibody and CTLA-4 antibody. 4. Patients have active autoimmune diseases. 5. Patients who need systemic corticosteroids (\> 10 mg prednisone/d) or other immunosuppressive drugs within 14 days before enrollment or during the study period. 6. Symptomatic central nervous system (CNS) disease (patients with asymptomatic treated CNS metastases were permitted) 7. Other malignant diseases within the past 5 years (patients with basal cell skin carcinoma and cervical carcinoma in situ were permitted) 8. Uncontrolled infection.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm triple-negative breast carcinoma

As listed by the trial registrant

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

Breast cancer TNBC - triple-negative breast cancer

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

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