Phase 3 Breast Cancer Trial, Recruiting NCT06279364 Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT06279364
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with triple-negative breast cancer (TNBC), confirmed through a tissue or cell sample test.
  • People whose cancer has either spread from the start (de novo metastatic) or has come back at least 6 months after finishing treatment that was intended to cure it.
  • People who have not yet received any systemic (whole-body) anti-cancer treatment for cancer that has spread or cannot be surgically removed.
  • People whose tumour tests negative for a protein called PD-L1, or whose tumour tests positive for PD-L1 but whose cancer returned after receiving a specific type of immunotherapy (anti-PD-1/PD-L1 treatment) for early-stage disease.
  • People who have at least one tumour that can be measured using standard imaging criteria.
  • People who are in good enough general health to carry out normal daily activities, with no decline in health in the 2 weeks before joining the trial (measured on a standard scale called ECOG, scored 0 or 1).
  • People who have a life expectancy of at least 3 months.
  • People whose treating doctor considers them suitable to receive at least one of the chemotherapy options listed in the trial (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin).
  • People whose liver, kidneys, bone marrow, and other organs are functioning well enough to meet the trial's health requirements.

Who may not be able to join:

  • People who currently have another active cancer.
  • People with significant or uncontrolled heart or blood vessel disease.
  • People who have had a history of lung inflammation (pneumonitis) or scarring lung disease (interstitial lung disease) not caused by infection that required steroid treatment, or who currently have either of these conditions.
  • People who have had an active infection requiring treatment with medicines taken throughout the body within 2 weeks before joining the trial.
  • People with an active hepatitis B or hepatitis C infection.
  • People who are HIV-positive, have a history of AIDS, or have a known active syphilis infection.
  • People who have a known allergy or sensitivity to the study drug (SKB264) or any of its ingredients.
  • People who have previously received a treatment that targets a protein called TROP2, or who have previously received a type of chemotherapy called a topoisomerase 1 inhibitor.
  • People who have previously received the same chemotherapy that would be assigned to them in this trial (with the exception of taxane-based chemotherapy).
  • People who are pregnant or currently breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 9 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 86-028-67255165

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
28 February 2024
Est. completion
1 July 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Overall Survival (OS); Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov