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New hope for aggressive breast cancer: two chemo cocktails face off in clinical trial

NCT ID NCT04159142

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 2 trial is testing two different chemotherapy combinations in 414 women with advanced triple-negative breast cancer (TNBC), a fast-growing type that lacks common treatment targets. One group gets nab-paclitaxel plus carboplatin, the other gets nab-paclitaxel plus capecitabine. The goal is to see which combo works better at slowing the cancer's growth and improving survival, while monitoring side effects.

What this could mean

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

Active substance
nab-paclitaxel plus carboplatin or capecitabine
What this could lead to
If successful, this could identify a more effective chemotherapy combination for advanced triple-negative breast cancer, potentially improving survival and delaying disease progression.
What could go wrong
This is a Phase 2 trial, so results are still early. Chemotherapy can cause significant side effects, and the benefit may be modest or not confirmed in larger studies.

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

About 414 people

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

Started

Nov 2019

Expected to finish

Sep 2028

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 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. Females with age between 18 to 70 years old; 2. Histologically confirmed triple negative breast cancer; 3. No more than one-line prior treatment for locally advanced or metastatic breast cancer; 4. Have at least one measurable lesion as per the RECIST criteria (version 1.1); 5. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one; 6. Patients with life expectancy of at least 3 months; 7. Bone marrow function:neutrophils (≥1.5×10\^9/L), platelets (≥100×10\^9/L), hemoglobin (≥90 g/L); 8. Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN; 9. Patients had good compliance with the planned treatment, understood the research process and written informed consent. Exclusion Criteria: 1. Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores; 2. Brain metastasis; 3. Recurrence or metastasis within 6 months after capecitabine withdrawal; 4. Recurrence or metastasis within 6 months after platinum withdrawal; 5. Progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months; 6. Patients required clinical intervention with gastrointestinal bleeding, gastrointestinal obstruction and non-feeding; 7. Patients who had Grade 2 or above Peripheral neuropathy; 8. Patients with severe systemic infection or other serious diseases; 9. Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants; 10. Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer; 11. Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial; 12. Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given; 13. The researchers considered the patients who were not suitable for enrollment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050011, China

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