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Triple Negative Breast CancerPhase 2NCT03348098

Clinical Study of Neoadjuvant Therapy With Apatinib and Paclitaxel in Local Advanced Triple-negative Breast Cancer

A Phase 2 study testing Apatinib and Paclitaxel in people with Triple Negative Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of apatinib in patient with TNBC Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
Apatinib and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
6 Sep 2017to 6 Dec 2018
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients between18 and 75 Years old;
  • patients with locally advanced breast cancer (TNM periodization:T is equal to or greater than 2,N is equal to 1,M is equal to 0)
  • clear for immunohistochemical is that: estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), the human epidermal growth factor receptor 2 is Negative ( IHC Her-2 0/+ , If ER- 、 PR- But Her-2 ++ , You need to do FISH/CISH Testing confirmed that Her-2 Amplification is negative);
  • The ECOG score is between 0 to 2 points;
  • The expected lifetime is ≥3 months;
  • Major organ function is normal, that meet the following criteria:
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  • Blood test standards subject to:
  • HB≥90 g/L ;
  • ANC≥1.5×109 /L ;
  • PLT≥100×109 /L ;
  • Biochemical examination must meet the following criteria:
  • TBIL≤1.5xULN ( upper limit of normal value ) ;
  • ALT AST≤2.5×ULN ;
  • Serum Cr≤1.5×ULN And endogenous creatinine clearance rate ≥50 mL/min (Cockcroft-Gault formula ) ;
  • the women of childbearing age must do the pregnancy test ( serum or urine ) within 7 days when they are included in the trial, And the result was negative, and during the trial and at the time of giving experimental drugs after 8 weeks using the appropriate methods of contraception;
  • no difficulty in swallowing, swallowing oral medications;
  • the participants volunteered to join this study should sign the informed consent forms, have better compliance, work in with the follow-up

Who cannot join

  • patients with pregnancy or lactation;
  • inflammatory breast cancer patients;
  • patients with several factors affecting medication (for example, inability to swallow, such as nausea, vomiting, chronic diarrhea, and bowel obstruction);
  • injury or pathologic fracture;
  • people with high blood pressure and antihypertensive drug treatment could not be reduced to within the normal range (systolic >140 mmHg, diastolic pressure >90 mmHg) ;
  • with ⅱ grade myocardial ischemia, poor control of arrhythmias or myocardial infarction (including QTc interval men ≥450 Ms, female ≥470 Ms);
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  • according to NYHA standard ⅲ~ⅳ -class heart insufficiency or heart ultrasound: LVEF(left ventricular ejection fraction) <50%;
  • the past 6 months have gastrointestinal bleeding within history or definite gastrointestinal bleeding, such as: risk of bleeding oesophageal varicose ulcer lesions, fecal occult blood, local activities ≥ (++) Into groups; such as the fecal occult blood (+), requires endoscopy;
  • prior to participating in the study of 28 days abdominal fistula, perforation of the gastrointestinal tract and abdominal abscesses;
  • positive patients of urinary protein (urine protein 2+ or above, or 24 -hour urine protein > 1.0g);
  • distant metastasis of patients with symptoms or are not controlled;
  • expected lifetime < 3 months;
  • into the group before 28 days to accept other anticancer treatment;
  • other information: dysfunction of blood coagulation (INR>1.5 or prothrombin time ( PT )> ULN+4 Seconds); Anticoagulant therapy are receiving antithrombotic or infection who needed intravenous antibiotics; previously receiving bevacizumab treatment or other anti- VEGF TKI Drug treatment, with a second tumor (except basal cell carcinoma and cervical carcinoma in situ);
  • a history of immunodeficiency, including HIV testing positive, or suffer from other acquired, congenital immune deficiency disease or have a history of organ transplantation;

Trial locations and contacts

1 site in 1 country.

Hong MD Liu, professor contact

18622221169

lh713@163.com

China1 site, 1 recruiting

  • TianJin Medical University Cancer Institute and Hospital

    Tianjin, 300060

    Hong MD Liu, professor, 18622221169, lh713@163.com

    Recruiting

Other trials in China

About this study

Official title: Tianjin Medical University Cancer Institute and Hospital

The purpose of this study is to evaluate the efficacy and safety of apatinib in patient with TNBC

Read the detailed description

NACT (Neoadjuvant chemotherapy) Increasingly widespread in clinical practice, there is still a substantial proportion of the patients NACT After failing to obtain ORR DCR , NACT Did not receive ORR DCR Patient access ORR DCR Patients have a higher risk of recurrence, and complete NACT The patient, the current standard therapy in the secondary stage of chemotherapy is no longer used, but non-ORR non-DCR After neo-adjuvant chemotherapy in patients with postoperative chemotherapy is worth exploring. Targeted drugs refer to interfere with tumor specific molecular processes and achieve inhibit or block the progression of drugs, its functioning is based on normal cells and tumor cells, differences, which makes the target specificity and side effects of the drug. Target drug is a pioneer in precision treatment of its interpretation of the individualized treatment based on the standard treatment. NCCN guidelines recommend paclitaxel in neoadjuvant chemotherapy is NACT first-line choice. At the Apatinib for dasatinib therapy in previous studies of breast cancer has a high level of performance, the Apatinib for dasatinib combined with paclitaxel in neoadjuvant therapy for breast cancer efficacy and safety is better than traditional treatments, is worthy of question.

Being tested
Apatinib, Paclitaxel
Keywords
Triple negative breast cancer
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApatinibDrug

    Also called YN968D1

    500 mg, po, qd. 12weeks

  • PaclitaxelDrug

    Also called Taxol

    drug: Paclitaxel ,80mg/m2, d1, Once a week , A total of 12 weeks; 3 weeks as a cycle

Study groups in NCT03348098
Study groupRoleWhat they receive
single armExperimentalApatinib Combined With Paclitaxel in Neoadjuvant Therapy of Locally Advanced Exploratory Research on Single-arm of TNBC
Receives: Drug: Apatinib; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    objective response rate

    Measured: ten months

Secondary outcomes (4)

  1. DCR

    disease control rate

    Measured: ten months

  2. pCR

    pathologic complete response

    Measured: ten months

  3. DFS

    disease free survival

    Measured: ten months

  4. Incidence of Treatment-Emergent Adverse Events [Safety]

    incidence of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03

    Measured: ten months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2017
  2. Study start6 Sep 2017
  3. Primary completion6 Jul 2018 (estimated)
  4. Study completion6 Dec 2018 (estimated)

Resources

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03348098
Sponsor's protocol ID
AHEAD TB001
Status last verified
Sep 2017
First submitted
9 Nov 2017
Last updated
28 Nov 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: the plan to share IPD is under consideration

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib and Paclitaxel in people with Triple Negative Breast Cancer, run by Tianjin Medical University Cancer Institute and 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 17 inclusion and 15 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 Nov 2017. 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 Hong MD Liu, professor (18622221169, lh713@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: ten months). 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 NCT03348098.

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 Nov 2017.

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