Breast CancerPhase 2NCT03735082
Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast Cancer
A Phase 2 study testing Apatinib, Paclitaxel and Carboplatin in people with Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast patients Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Apatinib, Paclitaxel and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 1 Jun 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 year-old women;
- Physical condition ECOG PS: 0-1;
- Previously untreated, histologically or cytologically confirmed to be triple negative breast cancer;
- Breast mass > 2cm, or ipsilateral lymph node metastasis (ipsilateral armpit, internal mammary, supraclavicle); Note: According to RECIST version 1.1, confirmed by CT or MRI,There must be at least one measurable lesion;If the target lesion is a lymph node requiring a short diameter greater than 1.5 cm, and the target lesion is not suitable for surgical treatment;
- Laboratory tests meet the following criteria: absolute count of blood neutrophils (ANC) ≥1.5×109/L; platelet (PLT)≥100×109/L; hemoglobin (HB)≥10g/dl; serum bilirubin ≤ 1.5 times the upper limit of normal value; AKP,ALT and AST≤2.5 times the upper limit of normal value;AKP, ALT and AST≤5 times the upper limit of normal value when liver metastasis;Urea nitrogen ≤ 1.5 times the upper limit of normal value,serum creatinine ≤ 1.5 times the upper limit of normal value;
- Expected survival time ≥ 3 months;
- Women of child-bearing age should be carried out pregnancy test (serum or urine) within 7 days before recruit, the results should be negative; and are willing to adopt the appropriate methods of contraception during the trial;
- Patients volunteered to join the study and signed informed consent.
Who cannot join
- There are other metastasis sites other than ipsilateral lymph node metastasis (ipsilateral armpit, internal mammary, supraclavicular);
- Have received anti-tumor treatment;
- Patients with hypertension who are not well controlled by antihypertensive medication (systolic pressure >140 mmHg, diastolic pressure >90 mmHg); have uncontrolled or severe cardiovascular disease, such as Refractory angina pectoris,congestive heart failure occurred within 6 months prior to screening ; myocardial infarction occurred within 12 months before screening; any clinically significant ventricular arrhythmia history, prolonged QT interval; history of cerebrovascular accident, symptomatic and medication required Coronary heart disease;
- Significant clinical dysfunction of the digestive tract may affect the intake, transport or absorption of oral medications (eg, inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- Patients with previous bleeding history, clinically significant bleeding symptoms, and patients with clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood + and above, vasculitis, etc.; urine protein positive patients;
- Major surgery or severe traumatic injury, fracture, or poor healing wound within 4 weeks;
Show all 9Show fewer
- Allergic to apatinib and/or its adjuvants, paclitaxel, carboplatin, etc.;
- Female patients during pregnancy or lactation, female patients with fertility and pregnancy test positive, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period
- The patient has a severe concomitant disease, or any other condition the investigator believes is not suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, ChineseAMS
Beijing, Beijing Municipality, 100021
Qiao LI, MD, 86-10-87788120, liqiaopumc@yahoo.cn
Binghe XU, MD, PHD, 86-10-87788495, xubinghe@medmail.com.cn
About this study
Official title: The Efficacy and Safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast Cancer :Single Arm, Phase II Clinical Trail
The purpose of this study is to assess the efficacy and safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast patients
Read the detailed description
Triple-negative breast cancer (TNBC) has the characteristics of early onset, high malignancy, less treatment, and resistance to treatment. Advanced patients have shorter survival than other subtypes. Changes in traditional chemotherapy regimens for breast cancer (ie, the addition of carboplatin) are potential ways to improve patient outcomes. Although anthracyclines and cyclophosphamide play a very positive role in the treatment of breast cancer, there are also small and serious long-term risks. Anti-angiogenic drugs are currently one of the few targeted therapies that have achieved some efficacy in TNBC. Apatinib, a targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with breast cancer. Considering of current status of anti-angiogenic drugs in the field of breast cancer, results of apatinib in advanced breast cancer, and current unmet clinical needs, the investigator conducted this study to assess the efficacy and safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast patients
- Conditions
- Breast Cancer
- Being tested
- Apatinib, Paclitaxel, Carboplatin
- 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,qd,d1-14,14day/cycle
PaclitaxelDrug
paclitaxel 175mg/m2,d1,14day/cycle+carboplatin AUC=4,d1,14day/cycle
CarboplatinDrug
carboplatin AUC=4,d1,14day/cycle;
| Study group | Role | What they receive |
|---|---|---|
| apatinib+Paclitaxel+Carboplatin | Experimental | apatinib 250mg, d1-14,14day/cycle; Paclitaxel 175mg/m2,d1,14days/cycle; Carboplatin AUC=4,d1,14day/cycle Receives: Drug: Apatinib; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
pCR defined as no invasive and non-invasive (DCIS) residuals in breast and armpit lymph nodes
Measured: 3 months
safety of treatment: Incidence of adverse events
Incidence of adverse events by maximum CTCAE grade (v4.03; NCI 2010)
Measured: every 2 weeks
Secondary outcomes (3)
rate of breast-pCR
breast-pCR defined as no invasive and non-invasive (DCIS) residuals in breast
Measured: 3 months
DFS
DFS defined as the time from drug onset until recurrence or death for various reasons.
Measured: up to 2 years
Rate of breast conserving surgery
Rate of patients with breast conserving surgery
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Nov 2018 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Qiao, Chinese Academy of Medical Sciences
- Investigators
- Qiao Li, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical SciencesBinghe Xu, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735082
- Sponsor's protocol ID
- LQ004
- Status last verified
- Nov 2018
- First submitted
- 5 Nov 2018
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu J, He M, Ou K, Wang X, Wang Y, Qi L, Chai Y, Jiang M, Ma F, Luo Y, Yuan P, Zhang P, Xu B, Li Q. Efficacy and safety of apatinib combined with dose-dense paclitaxel and carboplatin in neoadjuvant therapy for locally advanced triple-negative breast cancer: A prospective cohort study with propensity-matched analysis. Int J Cancer. 2024 Jan 1;154(1):133-144. doi: 10.1002/ijc.34717. Epub 2023 Sep 7.
PubMed 37676110
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast Cancer :Single Arm, Phase II Clinical Trail
- ClinicalTrials.gov ID
- NCT03735082
- Acronym / sponsor ID
- LQ004
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 8 Nov 2018 (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.
The purpose of this study is to assess the efficacy and safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast patients
Detailed description
Triple-negative breast cancer (TNBC) has the characteristics of early onset, high malignancy, less treatment, and resistance to treatment. Advanced patients have shorter survival than other subtypes. Changes in traditional chemotherapy regimens for breast cancer (ie, the addition of carboplatin) are potential ways to improve patient outcomes. Although anthracyclines and cyclophosphamide play a very positive role in the treatment of breast cancer, there are also small and serious long-term risks. Anti-angiogenic drugs are currently one of the few targeted therapies that have achieved some efficacy in TNBC. Apatinib, a targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with breast cancer. Considering of current status of anti-angiogenic drugs in the field of breast cancer, results of apatinib in advanced breast cancer, and current unmet clinical needs, the investigator conducted this study to assess the efficacy and safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| apatinib+Paclitaxel+Carboplatin | Experimental | Drug: Apatinib, Drug: Paclitaxel, Drug: Carboplatinapatinib 250mg, d1-14,14day/cycle; Paclitaxel 175mg/m2,d1,14days/cycle; Carboplatin AUC=4,d1,14day/cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 75 year-old women;
- Physical condition ECOG PS: 0-1;
- Previously untreated, histologically or cytologically confirmed to be triple negative breast cancer;
- Breast mass > 2cm, or ipsilateral lymph node metastasis (ipsilateral armpit, internal mammary, supraclavicle); Note: According to RECIST version 1.1, confirmed by CT or MRI,There must be at least one measurable lesion;If the target lesion is a lymph node requiring a short diameter greater than 1.5 cm, and the target lesion is not suitable for surgical treatment;
- Laboratory tests meet the following criteria: absolute count of blood neutrophils (ANC) ≥1.5×109/L; platelet (PLT)≥100×109/L; hemoglobin (HB)≥10g/dl; serum bilirubin ≤ 1.5 times the upper limit of normal value; AKP,ALT and AST≤2.5 times the upper limit of normal value;AKP, ALT and AST≤5 times the upper limit of normal value when liver metastasis;Urea nitrogen ≤ 1.5 times the upper limit of normal value,serum creatinine ≤ 1.5 times the upper limit of normal value;
Key exclusion criteria (9 listed)
- There are other metastasis sites other than ipsilateral lymph node metastasis (ipsilateral armpit, internal mammary, supraclavicular);
- Have received anti-tumor treatment;
- Patients with hypertension who are not well controlled by antihypertensive medication (systolic pressure >140 mmHg, diastolic pressure >90 mmHg); have uncontrolled or severe cardiovascular disease, such as Refractory angina pectoris,congestive heart failure occurred within 6 months prior to screening ; myocardial infarction occurred within 12 months before screening; any clinically significant ventricular arrhythmia history, prolonged QT interval; history of cerebrovascular accident, symptomatic and medication required Coronary heart disease;
- Significant clinical dysfunction of the digestive tract may affect the intake, transport or absorption of oral medications (eg, inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- Patients with previous bleeding history, clinically significant bleeding symptoms, and patients with clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood + and above, vasculitis, etc.; urine protein positive patients;
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,qd,d1-14,14day/cycle | Drug | apatinib+Paclitaxel+Carboplatin |
| Paclitaxelpaclitaxel 175mg/m2,d1,14day/cycle+carboplatin AUC=4,d1,14day/cycle | Drug | apatinib+Paclitaxel+Carboplatin |
| Carboplatincarboplatin AUC=4,d1,14day/cycle; | Drug | apatinib+Paclitaxel+Carboplatin |
Primary outcome
pCR rate
Time frame: 3 months
pCR defined as no invasive and non-invasive (DCIS) residuals in breast and armpit lymph nodes
safety of treatment: Incidence of adverse events
Time frame: every 2 weeks
Incidence of adverse events by maximum CTCAE grade (v4.03; NCI 2010)
3 secondary outcomes
rate of breast-pCR
Time frame: 3 months
DFS
Time frame: up to 2 years
Rate of breast conserving surgery
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Derived from this study: PubMed 37676110Liu J, He M, Ou K, Wang X, Wang Y, Qi L, Chai Y, Jiang M, Ma F, Luo Y, Yuan P, Zhang P, Xu B, Li Q. Efficacy and safety of apatinib combined with dose-dense paclitaxel and carboplatin in neoadjuvant therapy for locally advanced triple-negative breast cancer: A prospective cohort study with propensity-matched analysis. Int J Cancer. 2024 Jan 1;154(1):133-144. doi: 10.1002/ijc.34717. Epub 2023 Sep 7.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Qiao Li principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Binghe Xu principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Carboplatin in people with Breast Cancer, run by Chinese Academy of Medical Sciences 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 8 inclusion and 9 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 8 Nov 2018. 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 Binghe Xu (86-87788826 ext. 861087788120, xubinghe@medmall.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT03735082, 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 8 Nov 2018.