BridgeMD
New treatment option for Metastatic Breast Cancer
Official title Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT06900647
What this study is testing
What is Bortezomib (B)?
Bortezomib (B) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This a phase 1 study to evaluate the safety and preliminary efficacy of cisplatin combined with bortezomib in patients with recurrent or metastatic breast cancer.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Women aged 18 years and above with pathologically confirmed recurrent or metastatic advanced breast cancer ;
- The patient has tumor specimens (formalin-fixed, paraffin-embedded or fresh pre-treated recurrent tumor tissue);
- Patients who have failed standard treatment in the late stage;
- At least one measurable lesion;
- ECOG PS : 0-2 points;
You likely can't join if
- Any of the following will be considered as meeting the exclusion criteria of the study:
- Patients with acute active hepatitis B or acute active hepatitis C;
- Any serious underlying disease, comorbidity and active infection
- Currently receiving other anti-tumor treatments;
- History of epilepsy or epileptic-induced condition;
- Patients who are pregnant or breastfeeding;
See the full eligibility criteria
- Women aged 18 years and above with pathologically confirmed recurrent or metastatic advanced breast cancer ;
- The patient has tumor specimens (formalin-fixed, paraffin-embedded or fresh pre-treated recurrent tumor tissue);
- Patients who have failed standard treatment in the late stage;
- At least one measurable lesion;
- ECOG PS : 0-2 points;
- Estimated survival period ≥12 weeks;
- The function level of major organs meets the following standards: 1) The blood routine examination standards must meet: ANC ≥1.5×109/L, PLT ≥75×109/L, Hb ≥85g/L (no blood transfusion and blood products within 14 days...
- Any of the following will be considered as meeting the exclusion criteria of the study:
- Patients with acute active hepatitis B or acute active hepatitis C;
- Any serious underlying disease, comorbidity and active infection
- Currently receiving other anti-tumor treatments;
- History of epilepsy or epileptic-induced condition;
- Patients who are pregnant or breastfeeding;
- Those with poor compliance or unable to undergo normal follow-up;
- Allergic to study drugs;
- Patients diagnosed with other malignant tumors within 5 years, except for the following: surgically resected non-melanoma skin cancer, adequately treated cervical carcinoma in situ, surgically radically treated ductal...
- The researcher determines other situations that may affect the conduct of the clinical study and the determination of the study results.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.