Targeted treatment for a specific subtype of triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of VEGFR BP102 combined with nab-paclitaxel or a physician's choice of treatment in patients with the basal-like immune suppressed (BLIS) subtype of triple-negative breast cancer (TNBC). It focuses on individuals with locally advanced or metastatic TNBC who have not previously received chemotherapy or targeted therapy. The study aims to compare the outcomes of the new treatment regimen against standard treatment options in this specific patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ECOG Performance Status of 0-1
* Expected lifetime of not less than three months
* Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression) with BLIS subtype
* Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resection
* Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer
* At least one measurable or non-measurable lesion according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), which didn't receive radiation therapy
* The functions of major organs are basically normal
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm
* Have the cognitive ability to understand the protocol and be willing to participate and to be followed up

Exclusion Criteria:

* Symptomatic, untreated, or actively progressing CNS metastases
* Significant cardiovascular disease
* Adverse reactions of Grade ≥1 that are still continuing due to previous treatments. Exceptions are those of hair loss or which researchers take it as exception
* Major surgery was performed within 3 weeks of the first course of trial treatment (except for minor outpatient surgery, such as placement of vascular access)
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
* Other malignancies within 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or skin squamous cell carcinoma
* Inability to swallow, chronic diarrhea and intestinal obstruction, there are multiple factors that affect the use and absorption of drugs
* Presence of third-space fluid accumulation that cannot be controlled by drainage or other methods (such as excessive pleural fluid and ascites)
* Participated in clinical trials of other antitumor drugs within 4 weeks before first taking the investigational drug
* Long-term unhealing wound or incomplete healing of fracture
* Patients with known active HBV or HCV infection or hepatitis B DNA≥500, or chronic phase with abnormal liver function
* Allergic constitution, or known allergic history of the drug components of this trial; Or allergic to other monoclonal antibodies
* Patients with a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding within the past 6 months, such as esophageal varicose veins with bleeding risk, locally active ulcer lesions, stool occult blood ≥ (++), were not allowed to enter the group; If there is occult blood in the stool (+), gastroscopy is required
* Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before participating in this trial
* Urine protein ≥2+ and 24h urine protein quantitative \> 1.0 g
* Patients suffering from hypertension and unable to reach the normal range after antihypertensive drug treatment (systolic blood pressure \>140mmHg, diastolic blood pressure \>90mmHg)

Where it's running

• Breast cancer institute of Fudan University Cancer Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Zhimin Shao
• Email: zhimingshao@yahoo.com
• Phone: 86-021-64175590

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pre-Treatment Breast DCE-MRI AI Model to Predict Benefit from Neoadjuvant Chemo in Locally Advanced Triple-Negative Breast Cancer

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  Recruiting Fujian Cancer Hospital · Fuzhou, Fujian and 4 other locations · NCT07880600

• JS212-based therapy for recurrent/metastatic TNBC: as monotherapy or with partners

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  Recruiting Phase 2 Shanghai Junshi Bioscience Co., Ltd. · Beijing, Beijing Municipality and 30 other locations · NCT07876557

• Imaging study of [68Ga]Ga-DWJ155 in adults with solid tumors

  This trial tests a new radioligand imaging agent, [68Ga]Ga-DWJ155, to see how well it images tumors and how safe it is in adults with advanced solid cancers.

  Recruiting at 2 sites Phase 1 Novartis · Darlinghurst, New South Wales and 1 other locations · NCT07801508

• Can older adults with breast cancer tolerate a dense CMF chemo schedule

  This study tests whether giving a condensed CMF chemotherapy regimen is feasible for people 70 and older with breast cancer.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07768436

• Oral paclitaxel in triple-negative breast cancer before main chemotherapy

  This trial tests whether giving an oral paclitaxel dose-6 in combination with standard epirubicin and cyclophosphamide can be tolerated in women with triple-negative breast cancer before surgery.

  Recruiting Phase 1/2 The Affiliated Hospital Of Guizhou Medical University · Guiyang, Guizhou · NCT07739485

• Granzyme B-PET to see if immunotherapy works in TNBC

  This study will test whether a Granzyme B PET/CT scan can help predict how well immunotherapy will work for adults with locally advanced or metastatic triple-negative breast cancer receiving an immune checkpoint inhibitor.

  Recruiting Fudan University · Shanghai · NCT07705438

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.