Metastatic Breast CancerPhase 2NCT02687490
Abraxane in Patients With Visceral Metastases Dominant Metastatic Breast Cancer
A Phase 2 study testing Abraxane in people with Metastatic Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Abraxane in patients with visceral metastases dominant metastatic breast cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Abraxane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2017to 15 Dec 2020
- Phase
- Phase 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed metastatic breast cancer;
- Radiologically or histologically confirmed visceral dominant metastases;
- Patients who are expected to acquire benefit from chemotherapy: ER and/or PR positive patients who developed resistance after prior endocrine therapy; HER2+ patients who experienced disease progression on prior target therapy and are not suitable for subsequent target therapy; mTNBC patients who relapsed after platinum therapy;
- At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1);
- Patients who received paclitaxol in metastatic setting should be proven effective to prior paclitaxol based regimen and disease progressed after at least 3 months from the last administration of paclitaxol; those who received paclitaxel as neoadjuvant/adjuvant therapy can be enrolled if disease relapsed after at least 6 months from the completion of neoadjuvant/adjuvant chemotherapy. Patients who received docetaxol have no limitation for enrollment;
- Eastern Cooperative Oncology Group performance (ECOG) status of 0-1;
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- All patients enrolled are required to have adequate hematologic, hepatic, and renal function;
- Life expectancy longer than 12 weeks;
- No medical history of serious cardiovascular, hepatic, respiratory or renal diseases;
- Informed consent;
- Patients with good compliance.
Who cannot join
- Pregnant, lactating women or women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study;
- Patients who are expected to acquire benefit from endocrine or target therapy;
- Radiotherapy of axial bones within 4 weeks before enrollment or lack of recovery from prior radiotherapy;
- Treatment with other experimental drug within 4 weeks before enrollment;
- Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to enrollment;
- Other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia;
- Patients with a history of symptomatic cardiovascular, hepatic, respiratory, renal , hematological, endocrinal, neurological or psychiatric diseases;
- Uncontrolled serious infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-center, Open-Label, Phase II Study of Abraxane in Patients With Visceral Metastases Dominant Metastatic Breast Cancer
Abraxane in patients with visceral metastases dominant metastatic breast cancer
Read the detailed description
A Prospective, Single-center, Open-Label, Phase II Study of Abraxane in patients with visceral metastases dominant metastatic breast cancer
- Conditions
- Metastatic Breast Cancer
- Being tested
- Abraxane
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbraxaneDrug
125 mg/m2, D1, D8, D15
| Study group | Role | What they receive |
|---|---|---|
| Abraxane | Experimental | Abraxane: 125 mg/m2, D1, D8, D15 every 28 days Receives: Drug: Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Measured: 8 weeks
Secondary outcomes (3)
Objective Response Rate (ORR)
Measured: 8 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 8 weeks
Overall Survival (OS)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study start24 Feb 2017
- Primary completion1 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichun Hu, Fudan University
- Investigators
- Xichun Hu, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687490
- Sponsor's protocol ID
- Fudan BR2016-20
- Status last verified
- Feb 2021
- First submitted
- 17 Feb 2016
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xie Y, Gong C, Zhang J, Wang L, Cao J, Tao Z, Li T, Zhao Y, Li Y, Hu S, Wang B, Hu X. Phase II trail of nab-paclitaxel in metastatic breast cancer patients with visceral metastases. BMC Cancer. 2021 Nov 2;21(1):1174. doi: 10.1186/s12885-021-08921-2.
PubMed 34727875
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Open-Label, Phase II Study of Abraxane in Patients With Visceral Metastases Dominant Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02687490
- Acronym / sponsor ID
- Fudan BR2016-20
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 22 Feb 2016 (estimated)
- 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.
Abraxane in patients with visceral metastases dominant metastatic breast cancer
Detailed description
A Prospective, Single-center, Open-Label, Phase II Study of Abraxane in patients with visceral metastases dominant metastatic breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abraxane | Experimental | Drug: AbraxaneAbraxane: 125 mg/m2, D1, D8, D15 every 28 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed metastatic breast cancer;
- Radiologically or histologically confirmed visceral dominant metastases;
- Patients who are expected to acquire benefit from chemotherapy: ER and/or PR positive patients who developed resistance after prior endocrine therapy; HER2+ patients who experienced disease progression on prior target therapy and are not suitable for subsequent target therapy; mTNBC patients who relapsed after platinum therapy;
- At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1);
- Patients who received paclitaxol in metastatic setting should be proven effective to prior paclitaxol based regimen and disease progressed after at least 3 months from the last administration of paclitaxol; those who received paclitaxel as neoadjuvant/adjuvant therapy can be enrolled if disease relapsed after at least 6 months from the completion of neoadjuvant/adjuvant chemotherapy. Patients who received docetaxol have no limitation for enrollment;
Key exclusion criteria (8 listed)
- Pregnant, lactating women or women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study;
- Patients who are expected to acquire benefit from endocrine or target therapy;
- Radiotherapy of axial bones within 4 weeks before enrollment or lack of recovery from prior radiotherapy;
- Treatment with other experimental drug within 4 weeks before enrollment;
- Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to enrollment;
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 |
|---|---|---|
| Abraxane125 mg/m2, D1, D8, D15 | Drug | Abraxane |
Primary outcome
Progression Free Survival (PFS)
Time frame: 8 weeks
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: 8 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 8 weeks
Overall Survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Derived from this study: PubMed 34727875Xie Y, Gong C, Zhang J, Wang L, Cao J, Tao Z, Li T, Zhao Y, Li Y, Hu S, Wang B, Hu X. Phase II trail of nab-paclitaxel in metastatic breast cancer patients with visceral metastases. BMC Cancer. 2021 Nov 2;21(1):1174. doi: 10.1186/s12885-021-08921-2.
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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.
Xichun Hu, MD, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abraxane in people with Metastatic Breast Cancer, run by Fudan University 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 11 inclusion and 8 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: finished, as of the sponsor's last update on 1 Mar 2021. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02687490, which also lists 1 linked publication.
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 1 Mar 2021.