Advanced Triple Negative Breast CancerPhase 1/2NCT05019690
Apatinib Combined with Albumin-Bound Paclitaxel for Treatment of Advanced Triple Negative Breast Cancer
A Phase 1/2 study testing Apatinib Mesylate and Albumin-Bound Paclitaxel in people with Advanced Triple Negative Breast Cancer, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
This study is a single-arm,exploratory clinical study, to evaluate the effectiveness and safety of apatinib mesylate combined with albumin-bound paclitaxel for second-line treatment of advanced triple negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Triple Negative Breast Cancer
- What is being tested?
- Apatinib Mesylate and Albumin-Bound Paclitaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Jun 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Volunteered to participate in the study, signed the informed consent form. 2.Aged 18-75 years,female. 3.Histologically or pathologically confirmed advanced triple-negative breast cancer that meets the following criteria:
- Primary tumor stage determined by standard evaluation methods: CT0-4 /N0-3/M1;
- Pathologically confirmed breast cancer with negative HER2 expression, defined as < 10% immunoreactive cells with an IHC score of + or -,or in situ hybridization (ISH) resulting in no HER2 gene amplification (RATIO of HER2 gene signal to centromeric 17 signal < 2.0 and HER2 gene copy number/cell < 4.0);
- Negative hormone receptor status (ER and PgR) is known, which is defined as < 1% detected by immunohistochemistry;
- A previous systemic therapy, including anthracyclines, for recurrence/metastasis.
- 4.With measurable lesions,according to Response Evaluation Criteria In Solid Tumors Version 1.1.
Show all 10Show fewer
- 5.Patients must have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale.
- 6.Life expectancy ≥12 weeks. 7.No prior treatment with apatinib or albumin paclitaxel, except in neoadjuvant or adjuvant therapy.
- 8.Without serious system dysfunction and could tolerate chemotherapy. With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥80g/L (without blood transfusion during 14 days); a leucopenia count of ≥3.0×109/L; a platelet count of ≥90×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
- 9.Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 8 weeks after discontinuing study drug.
Who cannot join
- 1.Pregnant or lactating women. 2.Previous or coexisting malignancies, unless they are basal cell carcinoma of the skin, superficial bladder carcinoma, squamous cell carcinoma of the skin, cervical carcinoma in situ, or other cancers in situ that have achieved complete remission at least 5 years prior to screening and that do not require or are expected to require additional treatment during the study.
- 3.Patients with consciousness disorder or unable to cooperate with treatment, with mental illness or metastasis of central nervous system.
- 4. Patients who have participated in other clinical trials in the past three months.
- 5. Previous treatment with apatinib or other vaso-targeting drugs and other small-molecule tyrosine kinase inhibitors.
- 6. Received any targeted treatment before enrollment, including but not limited to the following: surgical treatment, chemotherapy, radiation therapy, targeted therapy, etc.
- 7. Within 3 months before treatment, esophageal (fundus) varices were ruptured and bleeding, intestinal obstruction and gastrointestinal perforation.
Show all 16Show fewer
- 8. The subject has clinical symptoms of cancerous ascites or pleural effusion. 9. Subjects have active infection or unexplained fever ≥38.5℃ within 7 days before enrollment.
- 10. Severe liver, kidney, heart, lung, brain and other major organ failure. 11. Patients with hypertension who cannot be reduced to the normal range after antihypertensive drug therapy (systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg).
- 12. Past or present idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, tissue pneumonia (e.g., bronchitis, angiitis oblitans), drug pneumonia, or screening CT with active pneumonia.
- 13. Patients with abnormal coagulation (INR > 1.5 or PROthrombin time (PT) > ULN+4 SEC), who are prone to bleeding, or who are receiving thrombolytic or anticoagulant therapy, are permitted to receive low-dose low-molecular heparin or oral aspirin procoagulant therapy during the trial.
- 14. Have cardiac clinical symptoms or disease that are not well controlled, e.g. :(1) nyha grade 2 Above heart failure;(2) Unstable angina;(3) Myocardial infarction occurred within 1 year;(4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;(5) QTc > 470ms.
- 15. Patients with positive protein urine (urine protein test of 2+ or above, or 24 h urine protein quantification > 1.0g).
- 16. Inability to swallow pills, malabsorption syndrome, or any condition that affects gastrointestinal absorption.
- 17. Overactivity/venous thrombosis events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, occurred within 6 months before enrollment.
- 18. A history of hereditary or acquired bleeding or coagulation disorders.Within 3 months before enrollment, patients with clinically significant bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.
- 19. According to the investigator's judgment, the subjects have other factors that may lead to the forced termination of the study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which may affect the safety of the subjects or the data collection, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
weiwei Huang, 13763893896, huangstudenth@163.com
About this study
Official title: Apatinib Mesylate Combined with Albumin-bound Paclitaxel for Second-line Treatment of Advanced Triple Negative Breast Cancer:a Single-arm,exploratory Clinical Study
This study is a single-arm,exploratory clinical study, to evaluate the effectiveness and safety of apatinib mesylate combined with albumin-bound paclitaxel for second-line treatment of advanced triple negative breast cancer.
Read the detailed description
This is a exploratory, single-arm, open-label trial. The investigator's primary purpose is to explore that PFS and safety of apatinib combined with albumin-bound paclitaxel for treatment of advanced triple negative breast cancer.
In treatment period, patients will be administrated apatinib plus albumin-bound paclitaxel, every 21 days for 1 cycle, until disease progression, toxicity intolerance, withdrawal of informed consent, patients judged must be terminated study termination.
The imaging evaluation was performed according to the RECIST 1.1 criteria every 6 weeks.
- Conditions
- Advanced Triple Negative Breast Cancer
- Being tested
- Apatinib Mesylate, Albumin-Bound Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib MesylateDrug
Also called apatinib
Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet,QD,Q3W
Albumin-Bound PaclitaxelDrug
Also called albumin paclitaxel
Subjects receive Albumin-Bound Paclitaxel,ivgtt, Strength: 125 mg/m^2,d1、7、15,Q3W
| Study group | Role | What they receive |
|---|---|---|
| Apatinib Combined With Albumin-Bound Paclitaxel | Experimental | Participants will receive apatinib combined with albumin-bound paclitaxel until predefined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first. Receives: Drug: Apatinib Mesylate; Drug: Albumin-Bound Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival(PFS)
PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
The PFS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median PFS, hazard ratio with appropriate confidence intervals will be reported.
Measured: From enrollment to 12 month
Secondary outcomes (3)
Overall Survival (OS)
Overall Survival (OS), defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication and participants with no post-baseline information were censored at the date of randomization.
The OS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median OS, hazard ratio with appropriate confidence intervals will be reported.
Measured: From enrollment to 24 month
Objective response rate(ORR)
ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.
The ORR will be reported by percentage with each arms and appropriate confidence intervals.
Measured: From enrollment to 12 month
Disease control rate(DCR)
DCR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR or SD. DCR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR or SD to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.
The DCR will be reported by percentage with each arms and appropriate confidence intervals.
[Time Frame: From enrollment to 12 month]
Measured: From enrollment to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Oct 2021
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019690
- Sponsor's protocol ID
- Arise-FJ-B02
- Status last verified
- Sep 2024
- First submitted
- 18 Aug 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apatinib Mesylate Combined with Albumin-bound Paclitaxel for Second-line Treatment of Advanced Triple Negative Breast Cancer:a Single-arm,exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT05019690
- Acronym / sponsor ID
- Arise-FJ-B02
- Conditions
- Advanced Triple Negative Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-arm,exploratory clinical study, to evaluate the effectiveness and safety of apatinib mesylate combined with albumin-bound paclitaxel for second-line treatment of advanced triple negative breast cancer.
Detailed description
This is a exploratory, single-arm, open-label trial. The investigator's primary purpose is to explore that PFS and safety of apatinib combined with albumin-bound paclitaxel for treatment of advanced triple negative breast cancer.
In treatment period, patients will be administrated apatinib plus albumin-bound paclitaxel, every 21 days for 1 cycle, until disease progression, toxicity intolerance, withdrawal of informed consent, patients judged must be terminated study termination.
The imaging evaluation was performed according to the RECIST 1.1 criteria every 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib Combined With Albumin-Bound Paclitaxel | Experimental | Drug: Apatinib Mesylate, Drug: Albumin-Bound PaclitaxelParticipants will receive apatinib combined with albumin-bound paclitaxel until predefined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1.Volunteered to participate in the study, signed the informed consent form. 2.Aged 18-75 years,female. 3.Histologically or pathologically confirmed advanced triple-negative breast cancer that meets the following criteria:
- 4.With measurable lesions,according to Response Evaluation Criteria In Solid Tumors Version 1.1.
- 5.Patients must have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale.
- 6.Life expectancy ≥12 weeks. 7.No prior treatment with apatinib or albumin paclitaxel, except in neoadjuvant or adjuvant therapy.
- 8.Without serious system dysfunction and could tolerate chemotherapy. With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥80g/L (without blood transfusion during 14 days); a leucopenia count of ≥3.0×109/L; a platelet count of ≥90×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
Key exclusion criteria (16 listed)
- 1.Pregnant or lactating women. 2.Previous or coexisting malignancies, unless they are basal cell carcinoma of the skin, superficial bladder carcinoma, squamous cell carcinoma of the skin, cervical carcinoma in situ, or other cancers in situ that have achieved complete remission at least 5 years prior to screening and that do not require or are expected to require additional treatment during the study.
- 3.Patients with consciousness disorder or unable to cooperate with treatment, with mental illness or metastasis of central nervous system.
- 4. Patients who have participated in other clinical trials in the past three months.
- 5. Previous treatment with apatinib or other vaso-targeting drugs and other small-molecule tyrosine kinase inhibitors.
- 6. Received any targeted treatment before enrollment, including but not limited to the following: surgical treatment, chemotherapy, radiation therapy, targeted therapy, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apatinib MesylateAlso: apatinibSubjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet,QD,Q3W | Drug | Apatinib Combined With Albumin-Bound Paclitaxel |
| Albumin-Bound PaclitaxelAlso: albumin paclitaxelSubjects receive Albumin-Bound Paclitaxel,ivgtt, Strength: 125 mg/m^2,d1、7、15,Q3W | Drug | Apatinib Combined With Albumin-Bound Paclitaxel |
Primary outcome
Progression-Free Survival(PFS)
Time frame: From enrollment to 12 month
PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. The PFS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median PFS, hazard ratio with appropriate confidence intervals will be reported.
3 secondary outcomes
Overall Survival (OS)
Time frame: From enrollment to 24 month
Objective response rate(ORR)
Time frame: From enrollment to 12 month
Disease control rate(DCR)
Time frame: From enrollment to 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Related trials for Advanced Triple Negative Breast Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1/2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (TNBC)
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
RecruitingPhase 1
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Apatinib Mesylate and Albumin-Bound Paclitaxel in people with Advanced Triple Negative Breast Cancer, run by Fujian Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact weiwei Huang (13763893896, huangstudenth@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival(PFS) (time frame: From enrollment to 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.