Primary Breast CancerPhase 4NCT03270007
Research of Intensive Treatment in Hormone Receptor<10% and Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer Patients With Positive Lymph Node Residual Disease After Neoadjuvant Chemotherapy
A Phase 4 study testing Vinorelbine in people with Primary Breast Cancer, run by Tao OUYANG at 1 site in China.
Trial summary
This is a phase IV, single-center, prospective, open-label, randomized,controlled study Read more about this study
- Who is it for?
- Ages 18 to 66 years, women only
- Conditions the study is for
- Primary Breast Cancer
- What is being tested?
- Vinorelbine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2017to 31 Dec 2024
- Phase
- Phase 4
- 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 66 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients, 18≦age ≦66 years
- Biopsy proven lymph node positive, estrogen receptor<10%、progesterone receptor <10% and human epidermal growth factor receptor-2 negative primary breast cancer
- Must have completed neo-adjuvant chemotherapy with a standard regimen(containing both anthracycline and paclitaxel)
- Must have undergone surgery to remove the primary tumor by either a mastectomy or enlarged local excision
- Postoperative residual positive lymph nodes
- Adequate recovery from recent surgery
Show all 22Show fewer
- No history of other malignancies
- No currently uncontrolled diseased or active infection
- Not pregnant or breast feeding, and on appropriate birth control if of child-bearing potential
- Adequate cardiovascular function reserve with a myocardial infarction within the past six month
- without radiotherapy and chemotherapy contraindication
- Adequate hematologic function with:
- Absolute neutrophil count (ANC) ≥1500/mm3
- Platelets ≥100,000/ mm3
- Hemoglobin ≥10 g/dL
- Adequate hepatic and renal function with:
- Serum bilirubin ≤1.5×UNL
- Alkaline phosphatase and alanine aminotransferase (ALT) ≤2.5 x ULN. (≤5 x ULN is acceptable in the setting of hepatic metastasis)
- BUN between 1.7 and 8.3 mmol/L
- Cr between 40 and 110 umol/L
- Knowledge of the investigational nature of the study and Ability to give informed consent
- Ability and willingness to comply with study procedures.
Who cannot join
- Known or suspected distant metastases
- Concurrent malignancy or history of other malignancy
- Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection
- Geographical, social, or psychological problems that would compromise study compliance
- Known or suspected hypersensitivity to vinorelbine
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Xing Wang, MD, 0086-10-88271119 ext. 8018, wangxing_susu@sina.com
About this study
This is a phase IV, single-center, prospective, open-label, randomized,controlled study
- Conditions
- Primary Breast Cancer
- Being tested
- Vinorelbine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinorelbineDrug
Also called Intensive treatment
different from primary chemotherapy(containing anthracycline or paclitaxel)
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Experimental | Not described Receives: Drug: Vinorelbine |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
distant disease-free survival (DDFS)
Measured: 5 years after surgery
Secondary outcomes (1)
relapse-free survival（RFS）、overall survival（OS）
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start10 Nov 2017
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 Primary Breast CancerStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tao OUYANG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tao OUYANG, Peking University
- Investigators
- Xing Wang, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270007
- Sponsor's protocol ID
- BCP19
- Status last verified
- Oct 2020
- First submitted
- 30 Aug 2017
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang X, He Y, Li J, Wang T, Fan Z, Ouyang T. Intensive treatment of triple negative breast cancer with residual positive axillary lymph node after neoadjuvant chemotherapy. BMC Womens Health. 2024 Nov 27;24(1):629. doi: 10.1186/s12905-024-03441-0.
PubMed 39604957
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Intensive Treatment in Hormone Receptor<10% and Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer Patients With Positive Lymph Node Residual Disease After Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT03270007
- Acronym / sponsor ID
- BCP19
- Conditions
- Primary Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Tao OUYANGUniversity, hospital or other
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Sep 2017 (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 is a phase IV, single-center, prospective, open-label, randomized,controlled study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Experimental | Drug: Vinorelbine |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Female patients, 18≦age ≦66 years
- Biopsy proven lymph node positive, estrogen receptor<10%、progesterone receptor <10% and human epidermal growth factor receptor-2 negative primary breast cancer
- Must have completed neo-adjuvant chemotherapy with a standard regimen(containing both anthracycline and paclitaxel)
- Must have undergone surgery to remove the primary tumor by either a mastectomy or enlarged local excision
- Postoperative residual positive lymph nodes
Key exclusion criteria (5 listed)
- Known or suspected distant metastases
- Concurrent malignancy or history of other malignancy
- Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection
- Geographical, social, or psychological problems that would compromise study compliance
- Known or suspected hypersensitivity to vinorelbine
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: Intensive treatmentdifferent from primary chemotherapy(containing anthracycline or paclitaxel) | Drug | Chemotherapy |
Primary outcome
distant disease-free survival (DDFS)
Time frame: 5 years after surgery
1 secondary outcome
relapse-free survival（RFS）、overall survival（OS）
Time frame: 5 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Derived from this study: PubMed 39604957Wang X, He Y, Li J, Wang T, Fan Z, Ouyang T. Intensive treatment of triple negative breast cancer with residual positive axillary lymph node after neoadjuvant chemotherapy. BMC Womens Health. 2024 Nov 27;24(1):629. doi: 10.1186/s12905-024-03441-0.
Related trials for Primary Breast Cancer
RecruitingObservational study
Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study
Mastectomy, Breast Neoplasm Malignant Primary
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingObservational study
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
Breast Cancer
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Recruiting
Researching the Effect of Exercise on Cancer
Breast Cancer, Prostate Cancer
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.
Xing Wang, MD principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vinorelbine in people with Primary Breast Cancer, run by Tao OUYANG 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 22 inclusion and 5 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 28 Oct 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Xing Wang, MD (0086-10-88271119 ext. 8018, wangxing_susu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
distant disease-free survival (DDFS) (time frame: 5 years after surgery). 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 NCT03270007, 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 28 Oct 2020.