Can adding a Blood-Vessel blocker boost chemotherapy for Triple-Negative breast cancer?

NCT ID NCT05192798

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This Phase 2 trial tests whether adding an antiangiogenic drug to standard chemotherapy helps people with relapsed or metastatic triple-negative breast cancer. Participants receive albumin-bound paclitaxel alone, or combined with either apatinib mesylate (a pill) or bevacizumab (an infusion). The study measures how long the cancer stays controlled and whether tumors shrink, while tracking 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
Albumin-bound paclitaxel combined with either apatinib mesylate or bevacizumab
What this could lead to
If adding an antiangiogenic agent improves progression-free survival, this could point toward a new first-line treatment option for relapsed or metastatic triple-negative breast cancer.
What could go wrong
This is a Phase 2 trial with 128 participants, so results may not hold up in larger studies. Adding these drugs can raise the risk of side effects like high blood pressure, bleeding, or fatigue.

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 128 people

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

Started

Jan 2022

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 80 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 years and ≤80 years; 2. Patients with recurrent or metastatic triple negative breast cancer confirmed by histopathology and imaging; 3. Presence of at least one measurable lesion according to RECIST 1.1; 4. Expected survival ≥3 months; 5. Eastern Cooperative Oncology Group performance status (ECOG PS) : 0-2; 6. Patients who have not previously received antitumor systemic therapy for the stage of relapse or metastasis; 7. For subjects who have previously undergone adjuvant/neoadjuvant therapy, the time from the end of the last chemotherapy (including taxanes) to randomization should be ≥12 months; The time from the end of radical radiotherapy to randomization should be ≥6 months. 8. Major organs show good function, and the relevant examination indexes within 7 days prior to randomization meet the following requirements: * Absolute neutrophil count ≥ 1.5 x 10\^9 / L; * Platelet count ≥ 100 x 10\^9 / L; * Hemoglobin ≥ 90 g/L; * Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤2.5 × upper limit of normal (ULN); ALT and AST≤5 × ULN if liver metastasis is present; * Creatinine clearance rate(Ccr) ≥60 mL/min according to the Cockcroft-Gault formula; * Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5 × ULN, and international normalized ratio (INR)≤1.5 × ULN. 9. Subjects voluntarily agree to participate in the study and sign informed consent, with good compliance and being accessible for treatment and follow-up. Exclusion Criteria: 1. Patients who are pregnant or breast-feeding; 2. Patients with multiple factors affecting oral medication (such as swallow inability, chronic diarrhea and intestinal obstruction); 3. Known hypersensitivity reaction to any of the components of the treatment; 4. Peripheral neuropathy ≥ grade 2, whatever the cause; 5. Serious other diseases as infections (hepatitis B, C and HIV), recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias or on screening, any of the following cardiac parameters: bradycardia (heart rate \<50 at rest) or heart rate-corrected QT interval via Fridericia (QTcF) ≥470 msec. 6. Patients with urinary protein ≥++ indicated by routine urine examination, and the 24-hour urine protein level was confirmed to be \> 1.0g; 7. Patients with imaging showing that the tumor has invaded important blood vessels or the investigator judges that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study; 8. Patients who have experienced arteriovenous or venous thrombosis events within 6 months prior to randomization, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 9. Any bleeding or bleeding event ≥grade 3 within 4 weeks prior to the first dose of therapy; Or the presence of unhealed wounds, fractures, gastrointestinal diseases such as gastric and duodenal active ulcers, ulcerative colitis, or active bleeding of unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator; 10. Uncontrolled effusion management (pleural effusion, pericardial effusion, or ascites) which requires frequent drainage procedures; 11. Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix; 12. Participants in clinical trials of other antitumor drugs within 4 weeks prior to randomization; 13. Other circumstances in which participation in the study would be inappropriate as determined by the investigator.

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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

  • Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College

    RECRUITING

    Bengbu, Anhui, 233004, China

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