Metastatic Breast CancerPhase 2NCT02607215
Platinum Rechallenge in Patients With Platinum-sensitive mTNBC
A Phase 2 study testing Vinorelbine and DDP in people with Metastatic Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Platinum Retreated in Patients with Platinum Sensitive mTNBC 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?
- Vinorelbine and DDP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Dec 2022
- 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
- Females with age between 18 and 70 years old
- Performance status no more than 2
- Life expectancy longer than 3 months
- Histological proven unresectable recurrent or advanced breast cancer
- Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (ER <1%, PR <1% and Her2 negative). A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+).
- Patients must have progressed after 1or 2 prior chemotherapy regimens for metastatic disease, cis/carbo-platin pretreated only 1 previous line prior to randomisation. Platinum sensitive in this study is defined as complete or partial or stable disease following completion (a minimum of 4 treatment cycles) of previous platinum-based chemotherapy and disease progression greater than 3 months after completion of their last dose of platinum chemotherapy (last dose).
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- At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
- Radiation therapy within 4 weeks prior to enrollment
- All patients enrolled are required to have adequate hematologic, hepatic, and renal function
- Be able to understand the study procedures and sign informed consent.
Who cannot join
- Patients had prior treatment with vinorelbine
- Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
- 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 the registration
- Treatment with an investigational product within 4 weeks before the first treatment
- Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction
- Uncontrolled serious infection
- Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Hospital
Shanghai, 200032
Xichun Hu, MD,PhD, 64175590 ext. 5006, huxicun@gmail.com
Zhonghua Wang, MD, 64175590 ext. 5000, zhonghuawang95@hotmail.com
About this study
Official title: Platinum Retreated in Second- or Third-line Patients With Platinum Sensitive Metastatic Triple Negative Breast Cancer (Randomised, Phase II, NPN Trial)
Platinum Retreated in Patients with Platinum Sensitive mTNBC
Read the detailed description
Platinum Retreated in Second- or Third-line Patients with Platinum Sensitive Metastatic Triple Negative Breast Cancer (randomised, phase II, NPN trial)
- Conditions
- Metastatic Breast Cancer
- Being tested
- Vinorelbine, DDP
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinorelbineDrug
Also called NVB
25 mg/m2, D1, D8
DDPDrug
75 mg/m2, D1
| Study group | Role | What they receive |
|---|---|---|
| Vinorelbine Plus DDP | Experimental | Vinorelbine:25 mg/m2, D1, D8 every 21 days
DDP:75 mg/m2, D1 every 21 days Receives: Drug: Vinorelbine; Drug: DDP |
| Vinorelbine | Active comparator | Vinorelbine:30 mg/m2, D1, D8 every 21 days Receives: Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Measured: 6 weeks
Secondary outcomes (3)
Objective Response Rate (ORR)
Measured: 6 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 6 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 posted17 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
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
- NCT02607215
- Sponsor's protocol ID
- Fudan BR2015-19
- Status last verified
- Apr 2022
- First submitted
- 16 Nov 2015
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platinum Retreated in Second- or Third-line Patients With Platinum Sensitive Metastatic Triple Negative Breast Cancer (Randomised, Phase II, NPN Trial)
- ClinicalTrials.gov ID
- NCT02607215
- Acronym / sponsor ID
- Fudan BR2015-19
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Nov 2015 (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.
Platinum Retreated in Patients with Platinum Sensitive mTNBC
Detailed description
Platinum Retreated in Second- or Third-line Patients with Platinum Sensitive Metastatic Triple Negative Breast Cancer (randomised, phase II, NPN trial)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vinorelbine Plus DDP | Experimental | Drug: Vinorelbine, Drug: DDPVinorelbine:25 mg/m2, D1, D8 every 21 days DDP:75 mg/m2, D1 every 21 days |
| Vinorelbine | Active comparator | Drug: VinorelbineVinorelbine:30 mg/m2, D1, D8 every 21 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Females with age between 18 and 70 years old
- Performance status no more than 2
- Life expectancy longer than 3 months
- Histological proven unresectable recurrent or advanced breast cancer
- Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (ER <1%, PR <1% and Her2 negative). A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+).
Key exclusion criteria (7 listed)
- Patients had prior treatment with vinorelbine
- Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
- 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 the registration
- Treatment with an investigational product within 4 weeks before the first treatment
- Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction
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 |
|---|---|---|
| VinorelbineAlso: NVB25 mg/m2, D1, D8 | Drug | Vinorelbine, Vinorelbine Plus DDP |
| DDP75 mg/m2, D1 | Drug | Vinorelbine Plus DDP |
Primary outcome
Progression Free Survival (PFS)
Time frame: 6 weeks
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: 6 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 6 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
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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 Vinorelbine and DDP 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 10 inclusion and 7 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 20 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xichun Hu, MD, PhD (64175590 ext. 5006, huxicun@gmail.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: 6 weeks). 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 20 Apr 2022.