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Breast NeoplasmsPhase 2NCT01653561

A Study of Apatinib in Non-triple-negative Metastatic Breast Cancer

A Phase 2 study testing Apatinib in people with Breast Neoplasms, run by Fudan University at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The hypothesis of this clinical research study is to discover if the study drug apatinib can shrink or slow the growth of pretreated non-triple-negative metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Apatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesChina
Study dates
Nov 2011to Oct 2012
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

  • ●≥ 18 and ≤ 70 years of age.
  • ECOG performance status of 0-1.
  • Metastatic breast cancer, confirmed by histological analysis.
  • Have experienced at least 1 and at most 4 regimens, and failed from the last chemotherapy regimen. Pretreated anthracycline, taxanes and capecitabine (any rational reason for no use of capecitabine is acceptable) are mandatory.
  • Women diagnosed with human epidermal growth factor receptor positive (HER2+) should have failed for at least 1 anti-HER2 therapy (any rational reason for no use of anti-HER2 therapy is acceptable). HER2+ is defined as +++ staining on immunohistochemistry or FISH/CISH positive for gene amplification.
  • Women diagnosed with HR+ should have failed for at least 1 hormonal therapy.
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  • Have failed for at least one chemotherapy regimen, but at most three regimens(including adjuvant and neo-adjuvant setting).
  • Duration from the last therapy (chemotherapy, radiotherapy, target therapy and operation) is more than 4 weeks (Duration for nitroso or mitomycin is 6 weeks).
  • Have at least one extracranial measurable site of disease according to RECIST 1.0 criteria that has not been previously irradiated.
  • Life expectancy of more than 3 months.
  • Negative serum or urine pregnancy test taken in all women within 7 days before inclusion. Sexually active women of childbearing potential must use a medically acceptable form of contraception from the beginning of the study to 8 weeks after the last dose of the investigated drug.
  • Written informed consent prior to study specific screening procedures.

Who cannot join

  • Triple-negative breast cancer (ER-, PR- and HER2-. HER2- is defined as 0 or 1+ staining on immunohistochemistry or FISH/CISH negative for gene amplification. )
  • Pregnant or lactating women.
  • Less than 4 weeks from the last clinical trial.
  • Uncontrolled hypertension with mono-drug therapy (>140/90 mm Hg)；ischemia of the myocardium （≥ grade 2） or myocardial infarction；arrhythmia（≥ grade 2, QTcF > 470ms for female patients） or New York Heart Association Class III/IV
  • Any factors that influence the usage of oral administration.
  • The cumulative doses of doxorubicin and epirubicin before inclusion have surpassed 300 mg/m2 and 600 mg/m2, respectively.
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  • Duration from the last therapy (chemotherapy, radiotherapy, target therapy and operation) is less than 4 weeks (Duration for nitroso or mitomycin is less than 6 weeks).
  • Confirmed brain metastasis.
  • Inadequate hepatic, renal, heart, and hematologic functions (hemoglobin <90g/L, neutrophils < 1.5×10^9/L, platelets < 80×10^9/L , ALT > 2.5 x upper limit of normal (ULN)(5x for liver metastasis), AST > 2.5 x ULN (5x for liver metastasis), serum bilirubin > 1.5 x ULN, serum creatine > 1.0 x ULN, creatinine clearance rate ≤ 50ml/min, LVEF < lower limit of normal (LLN).
  • Abnormal coagulative function, inclined to bleeding or is receiving thrombolytictherapy or anticoagulation.
  • History of arterial/venous embolic events (such as cerebrovascular accident, TIA, deep vein thrombus,and pulmonary embolism)
  • Unhealed wound (> 30 days) or bone fracture.
  • Urine protein ≥++ and confirmed >1.0 g by the 24h quantity.
  • Previous or present history of pulmonary fibrosis,interstitial pneumonia,pneumoconiosis,radiation pneumonitis,drug-related pneumonitis or greatly-impaired pulmonary function.
  • Disability of serious uncontrolled intercurrence infection.
  • Abuse of alcohol or drugs.
  • Have received prior treatment with a VEGFR, PDGFR or s-SRC TKI (Bevacizumab is permitted).
  • Acquired or inherent immunodeficiency； HIV infection； organ transplantation history.
  • The active HBV or HCV infection or HBV DNA ≥10^4/ml.
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix.
  • Presence of serious harm to subjects or complication to hinder the completion of the study judged by investigators

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality, 200032

  • Fudan University Cancer Hospital

    Shanghai, 200032

Other trials in China

About this study

Official title: A Multi-institutional, Open-label, Single Arm Study of Apatinib in Non-triple-negative Metastatic Breast Cancer

The hypothesis of this clinical research study is to discover if the study drug apatinib can shrink or slow the growth of pretreated non-triple-negative metastatic breast cancer.

Read the detailed description

Apatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor (VEGFR), and its anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The hypothesis of this clinical research study is to discover if the study drug apatinib can shrink or slow the growth of non-triple-negative breast cancer. The safety of apatinib will also be studied. Patients physical state, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if apatinib is safe and effective in pretreated non-triple-negative metastatic breast cancer patients.

Being tested
Apatinib
Keywords
Metastatic breast cancer, Apatinib, non-triple-negative
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

    The starting dose of apatinib will be 500mg/d. Two dose reductions will be allowed to 375 and then 250 mg/d.

Study groups in NCT01653561
Study groupRoleWhat they receive
ApatinibExperimentalApatinib 500mg/d
Receives: Drug: Apatinib

What is being measured

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

  1. PFS(Progression free survival)

    Measured: 8 Weeks

Secondary outcomes (5)

  1. ORR (Objective response rate)

    Measured: 8 Weeks

  2. CBR(Clinical benefit rate)

    Measured: 8 Weeks

  3. OS (Overall survival)

    Measured: 8 Weeks

  4. QoL (Quality of life)

    Measured: 8 Weeks

  5. Toxicity (Number of adverse events)

    Measured: 8 Weeks

Timeline

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

  1. First posted31 Jul 2012 (estimated)
  2. Study startNov 2011
  3. Primary completionOct 2012
  4. Study completionOct 2012

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 (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01653561
Sponsor's protocol ID
Fudan BR2012-08
Status last verified
Aug 2013
First submitted
10 Jul 2012
Last updated
3 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Hu X, Cao J, Hu W, Wu C, Pan Y, Cai L, Tong Z, Wang S, Li J, Wang Z, Wang B, Chen X, Yu H. Multicenter phase II study of apatinib in non-triple-negative metastatic breast cancer. BMC Cancer. 2014 Nov 7;14:820. doi: 10.1186/1471-2407-14-820.

    PubMed 25376790

  • Fan M, Zhang J, Wang Z, Wang B, Zhang Q, Zheng C, Li T, Ni C, Wu Z, Shao Z, Hu X. Phosphorylated VEGFR2 and hypertension: potential biomarkers to indicate VEGF-dependency of advanced breast cancer in anti-angiogenic therapy. Breast Cancer Res Treat. 2014 Jan;143(1):141-51. doi: 10.1007/s10549-013-2793-6. Epub 2013 Dec 1.

    PubMed 24292957

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib in people with Breast Neoplasms, run by Fudan University at 2 sites 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 12 inclusion and 21 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: finished, as of the sponsor's last update on 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

PFS(Progression free survival) (time frame: 8 Weeks). 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 NCT01653561, which also lists 2 linked publications.

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 3 Dec 2013.

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