Breast CancerPhase 2APPNCT03982485
Combination Neoadjuvant Chemotherapy With or Without Apatinib for HER2 Negative Breast Cancer
A Phase 2 study testing Apatinib, Paclitaxel and Cisplatin in people with Breast Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
RATIONALE: The combination of anti-angiogenic targeted therapy with neoadjuvant chemotherapy has been shown to further improve the pathologic response rate for HER2-negative breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Apatinib, Paclitaxel and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2018to 29 Mar 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 18~70 year-old，Female
- Patients with histologically confirmed primary invasive breast adenocarcinoma,cT2-4N0-3M0
- ECOG 0-1
- HER2-negative tumor in biopsy, defined as: Immunohistochemical (IHC) 0-1+ or IHC 2+ confirmed as FISH negative.
- Adequate organ function
Who cannot join
- Unwilling to use adequate contraceptive protection during the process of the study and for at least 8 weeks after the last dose of study drug.
- Pregnant or breastfeeding patients
- Metastatic or recurrent patients
- Any evidence of sense or motor nerve disorders
- Any concurrent malignancy other than breast cancer
- Uncontrolled hypertension with hypotensive drugs therapy (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg). Patients with grade I or above myocardial ischemia or myocardial infarction or arrhythmia (including QT interval ≥ 440 ms) or cardiac insufficiency
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- Inability to swallow, gastrointestinal resection, chronic diarrhea and obstruction of the intestine, various factors which affect drug use and absorption
- Coagulation disorders
- Artery or venous thrombosis occurred within 6 months before the study begins
- Have received prior treatment with a VEGFR TKI
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Neoadjuvant Apatinib Added to Weekly Paclitaxel and Cisplatin in Patient With Locally Advanced or Early Stage HER2 Negative Breast Cancer (APP) : a Open-label, Randomized, Controlled, Trial
RATIONALE:
The combination of anti-angiogenic targeted therapy with neoadjuvant chemotherapy has been shown to further improve the pathologic response rate for HER2-negative breast cancer patients. Apatinib is a highly potent human vascular endothelial growth factor receptor 2 (VEGFR2) tyrosine kinase inhibitor that has been independently developed in China, and it can exert anti-angiogenic effects by inhibiting VEGFR2. It is unknown whether giving combination neoadjuvant chemotherapy together with apatinib is more effective in treating patients with nonmetastatic HER2-negative breast cancer.
Read more
PURPOSE:
To explore the efficacy and safety of apatinib added to weekly paclitaxel and cisplatin neoadjuvant therapy for HER-2 negative breast cancer patients
- Conditions
- Breast Cancer
- Being tested
- Apatinib, Paclitaxel, Cisplatin, Surgery
- Keywords
- Apatinib, Neoadjuvant chemotherapy, Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Apatinib 250mg, Oral, day 2,3,4,5,6,7, every week
PaclitaxelDrug
Paclitaxel 80mg/m2, Intravenous, day 1, 8, 15, 22, every 28 days for a cycle
CisplatinDrug
Cisplatin 25mg/m2, Intravenous, day 1, 8, 15, every 28 days for a cycle
SurgeryProcedure or surgery
Surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Apatinib+Paclitaxel+Cisplatin Receives: Drug: Apatinib; Drug: Paclitaxel; Drug: Cisplatin; Procedure: Surgery |
| Arm II | Active comparator | Paclitaxel+Cisplatin Receives: Drug: Paclitaxel; Drug: Cisplatin; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual cancer burden (RCB 0-I rates）
RCB 0-I rates means RCB 0+I (good response) rates.
Measured: Time of surgery
Pathologic Complete Response (pCR) of the Primary Tumor in the Breast
Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen.
Measured: Time of surgery
Secondary outcomes (8)
pCR in the Breast and Nodes
Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen and axillary lymph nodes.
Measured: Time of surgery
Near pCR in the Breast
Percentage of patients with the residual breast lump Less than 10%
Measured: Time of surgery
Clinical and imaging response
To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment
Measured: Time of surgery
Number of Participants With Drug Related Treatment Adverse Events
Adverse events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state.
Measured: an average of 16 weeks
Neo-bioscore
The Neo-Bioscore staging points were determined for each patient based on information from the medical records according to the previously published work（Mittendorf EA, et al. The Neo-Bioscore Update for Staging Breast Cancer Treated With Neoadjuvant Chemotherapy: Incorporation of Prognostic Biologic Factors Into Staging After Treatment. JAMA Oncol. United States; 2016;2:929-36.）.
Neo-Bioscore = Clinical stages score + Pathological stages score + Tumor marker score Clinical stage I =0, Clinical stage IIA =0, Clinical stage IIB =1, Clinical stage IIIA =1, Clinical stage IIIB =2, Clinical stage IIIC =2, Pathological stage 0 =0, Pathological stage I =0, Pathological stage IIA =1, Pathological stage IIB =1, Pathological l stage IIIA =1, Pathological stage IIIB =1, Pathological stage IIIC =2, Tumor marker ER negative=1 Tumor marker Grade3=1 Tumor marker ERBB2 negative=1
Measured: Time of surgery
Disease-free Survival (DFS)
DFS is defined as the time period between registration and first event
Measured: Measured through 5 years after study enrollment
Distant-disease- free survival (DDFS)
DDFS is defined as the time period between registration and first event
Measured: Measured through 5 years after study enrollment
Overall survival (OS)
OS is defined as the time period between registration and first event
Measured: Measured through 5 years after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start16 Oct 2018
- Primary completion29 Mar 2023
- Study completion29 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinsong Lu, MD, Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982485
- Sponsor's protocol ID
- SHPD005
- Acronym
- APP
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2019
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Apatinib Added to Weekly Paclitaxel and Cisplatin in Patient With Locally Advanced or Early Stage HER2 Negative Breast Cancer (APP) : a Open-label, Randomized, Controlled, Trial
- ClinicalTrials.gov ID
- NCT03982485
- Acronym / sponsor ID
- APP / SHPD005
- Conditions
- Breast Cancer
- Keywords
- Apatinib, Neoadjuvant chemotherapy, Breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 196 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2031 (estimated)
- First posted
- 11 Jun 2019 (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.
RATIONALE:
The combination of anti-angiogenic targeted therapy with neoadjuvant chemotherapy has been shown to further improve the pathologic response rate for HER2-negative breast cancer patients. Apatinib is a highly potent human vascular endothelial growth factor receptor 2 (VEGFR2) tyrosine kinase inhibitor that has been independently developed in China, and it can exert anti-angiogenic effects by inhibiting VEGFR2. It is unknown whether giving combination neoadjuvant chemotherapy together with apatinib is more effective in treating patients with nonmetastatic HER2-negative breast cancer.
PURPOSE:
To explore the efficacy and safety of apatinib added to weekly paclitaxel and cisplatin neoadjuvant therapy for HER-2 negative breast cancer patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: Apatinib, Drug: Paclitaxel, Drug: Cisplatin, Procedure: SurgeryApatinib+Paclitaxel+Cisplatin |
| Arm II | Active comparator | Drug: Paclitaxel, Drug: Cisplatin, Procedure: SurgeryPaclitaxel+Cisplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18~70 year-old，Female
- Patients with histologically confirmed primary invasive breast adenocarcinoma,cT2-4N0-3M0
- ECOG 0-1
- HER2-negative tumor in biopsy, defined as: Immunohistochemical (IHC) 0-1+ or IHC 2+ confirmed as FISH negative.
- Adequate organ function
Key exclusion criteria (10 listed)
- Unwilling to use adequate contraceptive protection during the process of the study and for at least 8 weeks after the last dose of study drug.
- Pregnant or breastfeeding patients
- Metastatic or recurrent patients
- Any evidence of sense or motor nerve disorders
- Any concurrent malignancy other than breast cancer
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 |
|---|---|---|
| ApatinibApatinib 250mg, Oral, day 2,3,4,5,6,7, every week | Drug | Arm I |
| PaclitaxelPaclitaxel 80mg/m2, Intravenous, day 1, 8, 15, 22, every 28 days for a cycle | Drug | Arm I, Arm II |
| CisplatinCisplatin 25mg/m2, Intravenous, day 1, 8, 15, every 28 days for a cycle | Drug | Arm I, Arm II |
| SurgerySurgery | Procedure or surgery | Arm I, Arm II |
Primary outcome
Residual cancer burden (RCB 0-I rates）
Time frame: Time of surgery
RCB 0-I rates means RCB 0+I (good response) rates.
Pathologic Complete Response (pCR) of the Primary Tumor in the Breast
Time frame: Time of surgery
Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen.
8 secondary outcomes
pCR in the Breast and Nodes
Time frame: Time of surgery
Near pCR in the Breast
Time frame: Time of surgery
Clinical and imaging response
Time frame: Time of surgery
Number of Participants With Drug Related Treatment Adverse Events
Time frame: an average of 16 weeks
Neo-bioscore
Time frame: Time of surgery
Disease-free Survival (DFS)
Time frame: Measured through 5 years after study enrollment
Distant-disease- free survival (DDFS)
Time frame: Measured through 5 years after study enrollment
Overall survival (OS)
Time frame: Measured through 5 years after study enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
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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.
Jinsong Lu, MD principal investigator
Renji Hospital, School of Medicine, Shanghai Jiao Tong 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 Apatinib, Paclitaxel and Cisplatin in people with Breast Cancer, run by RenJi 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 5 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Residual cancer burden (RCB 0-I rates） (time frame: Time of surgery). The study lists 2 primary outcomes in all. 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 30 Apr 2024.