AzTrials
AzTrials

Breast Cancer MetastaticPhase 1NCT05301530

Clinical Trial to Assess Pharmacokinetic Parameters and Safety of NNG-TMAB (Trastuzumab) on Recurrent or Metastatic Breast Cancer Patients.

A Phase 1 study testing Faceptor, Herceptin and Docetaxel in people with Breast Cancer Metastatic and Breast Cancer Female, run by Nanogen Pharmaceutical Biotechnology Joint Stock Company at 2 sites in Vietnam.

Completed

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

Official record
Search all trials

Trial summary

Targeted therapy in the treatment of breast cancer targets HER2 receptor (Human Epidermal growth factor Receptor). HER2 receptor plays an important role in cell growth and differentiation (5). However, when HER2 overexpresses, it may lead to cancer. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
Faceptor, Herceptin and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesVietnam
Study dates
27 May 2019to 19 Feb 2021
Phase
Phase 1
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 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients from 18 to 65 years old.
  • Willing to give written and signed informed consent.
  • Have pathologically or cytologically confirmed breast cancer.
  • Inoperable, recurrent or metastatic breast cancer according to TNM classification and investigator' s assessment.
  • Presence of at least 1 tumour with a size not less than 1 cm (revealed with computed tomography (CT) slice thickness not more than 5 mm). Patients having bone metastasis as the only measurable tumour are not eligible for the trial.
  • Grade 3+ HER2 overexpression confirmed by immunohistochemical (IHC) staining or grade 2+ HER2 overexpression accompanied by HER2 gene amplification confirmed by fluorescent hybridization in situ (FISH).
Show all 11Show fewer
  • Eastern Cooperative oncology group performance status ≤ 2
  • Willing to comply the requirements of the study protocol.
  • Have a survival expectancy of at least 6 months.
  • At screening period: Hb ≥ 9 g/dL; Neutrophils ≥ 1,5x10^9/L; platelets ≥ 100x10^9/L; creatinine level ≤ 1,5 x upper limit of normal (ULN); bilirubin level < 1,5 x ULN; ALT/AST < 2,5 x ULN (< 5 x ULN for patients with liver metastases), ALP < 5 x ULN.
  • Patients of childbearing potential and her partner must implement reliable contraceptive measures during the study treatment, starting 4 weeks prior to inclusion into the trial and until 6 months after the last administration of the study drug

Who cannot join

  • Previous anticancer therapy for metastatic BC, including previous anticancer therapy with signal transduction inhibitors (e.g. lapatinib), biological drugs (e.g. trastuzumab, bevacizumab), experimental (not approved for BC therapy) anticancer drugs. Any previous chemotherapy or hormonal therapy is allowed.
  • Previously treated with doxorubicin > 400 mg/m2; epirubicin > 800 mg/m2 in accumulative dosages.
  • Surgery, radiation therapy, use of any experimental medications within 4 weeks prior to randomization.
  • Clinical evidence or X-ray show that breast cancer metastases in central nervous system
  • Patients with metastatic tumor to the bone is the only tumor to be measured
  • Systolic blood pressure >150mmHg and/or diastolic blood pressure >100mmHg. Uncontrolled hypertension comprising all cases of arterial hypertension when no decrease in blood pressure could be achieved despite treatment with a combination of 3 antihypertensive drugs including one diuretic and non-medicamental correction methods (low salt diet, physical exercise)
Show all 11Show fewer
  • Cardiovascular system pathology (congestive heart failure (CHF) stage III-IV according to New York Heart Association (NYHA) classification, unstable angina pectoris, myocardial infarction) within 12 months prior to randomization. LVEF < 50% according to echocardiogram when screening.
  • Acute or chronic infection (except for acute or chronic infection that is stable and does not affect the study evaluation). Infecting HIV, HBV or HCV, Syphilis
  • Patients with a history of severe allergic reaction to trastuzumab, paclitaxel, docetaxel or other ingredients in the formulation
  • The patient has evidence of a serious illness (such as resting dyspnea or severe lung disease, etc.) or an abnormal laboratory test that, in the judgment of the researcher, will affect participation. research and completion of patient research, or may affect the patient's response evaluation.
  • Pregnancy, intend to get pregnant, lactation

Trial locations and contacts

2 sites in 1 country.

Vietnam2 sites

  • 19-8 Hospital

    Hanoi

  • HCMC Oncology Hospital

    Ho Chi Minh City

Other trials in Vietnam

About this study

Official title: Randomized, Single-blind, Multicenter, Parallel Group Clinical Trial to Assess Pharmacokinetic Parameters, Safety of NNG-TMAB (Trastuzumab) in Combination With Docetaxel on Recurrent or Metastatic Breast Cancer Patients With Positive HER2.

Targeted therapy in the treatment of breast cancer targets HER2 receptor (Human Epidermal growth factor Receptor). HER2 receptor plays an important role in cell growth and differentiation (5). However, when HER2 overexpresses, it may lead to cancer. HER2 positive malignance exacerbates pathology and worsens clinical outcome, such as shortened overall survival (OS) compared with non-HER2 overexpression patients (6), (7). About 20-30% overexpression HER2/neogene breast cancer patients and patients having HER2 overexpression tumor have disease progression and poor prognosis in metastatic process (8), (9).

Currently, targeted therapeutic, which attaches to the HER2 receptor, inhibiting the growth of cancer cells has been approved. One of these products is Trastuzumab.

Read more

The study processed on 50 females aged between 18 and 65, recurrent or metastatic breast cancer patients with positive HER2.

The subjects were randomly distributed in 2 groups as NNG-TMAB + docetaxel or Herceptin® + docetaxel, in blocks of 4 in a 1:1 ratio (NNG-TMAB: Herceptin®). In each block of 4 will be 2 patients in the experimental group and 2 patients in the control group.

Primary endpoint is serum peak concentrations (Cmax), area under the curve from 0 to t (AUC0-t).

This trial is intended to assess the biosimilarity of pharmacokinetic parameters, safety between Faceptor (experimental drug) and Herceptin (reference).

Being tested
Faceptor, Herceptin, Docetaxel

What participants receive

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

  • FaceptorDrug

    Also called NNG-TMAB, Trastazumab

    NNG-TMAB (trastuzumab) 150 mg, 440 mg, lyophilized power for injection, manufacturered by Nanogen Pharmaceutical Biotechnology JSC.

  • HerceptinDrug

    Also called Trastuzumab

    Herceptin (trastuzumab) 150mg, 440mg, powder for concentrate for solution, manufactured by Roche.

  • DocetaxelDrug

    Also called Taxotere

    The drug Docetaxel in this study has the brand name Taxotere manufactured by Sanofi company.

Study groups in NCT05301530
Study groupRoleWhat they receive
Faceptor + DocetacelExperimentalPatients received a loading dose of Faceptor 8 mg/kg IV + docetaxel 75 mg/m^2 IV on Cycle 1 followed by Faceptor 6 mg/kg IV + docetaxel 75 mg/m^2 IV on the next 5 cycles (each cycle is 21 days)
Receives: Drug: Faceptor; Drug: Docetaxel
Herceptin + DocetacelActive comparatorPatients received a loading dose of Herceptin 8 mg/kg IV + docetaxel 75 mg/m^2 IV on Cycle 1 followed by Herceptin 6 mg/kg IV + docetaxel 75 mg/m^2 IV on the next 5 cycles (each cycle is 21 days)
Receives: Drug: Herceptin; Drug: Docetaxel

What is being measured

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

  1. Pharmacokinetic parameters: Cmax

    Serum peak concentrations (Cmax)

    Measured: Blood samples will be collected at following time points: prior to IP administration; 1.5; 3; 4.5; 6; 24; 96; 168; 336 and 504 hours after inject drug cycle 1

  2. Pharmacokinetic parameters: AUC0-t

    Area under the curve from 0 to t (AUC0-t)

    Measured: Blood samples will be collected at following time points: prior to IP administration; 1.5; 3; 4.5; 6; 24; 96; 168; 336 and 504 hours after inject drug cycle 1

Secondary outcomes (5)

  1. Pharmacokinetic parameters: Ctrough

    Serum trough concentration (Ctrough)

    Measured: Blood samples will be collected at following time points: day 23rd, 65th, 107th and 128th (at the beginning of visits 4, 8, 12, 14)

  2. Pharmacokinetic parameters: AUC0-∞

    Area under the curve from 0 to ∞ (AUC0-∞)

    Measured: Blood samples will be collected at following time points: prior to IP administration; 1.5; 3; 4.5; 6; 24; 96; 168; 336 and 504 hours after inject drug cycle 1

  3. Pharmacokinetic parameters: Tmax

    Time for the drug to reach peak concentration (Tmax)

    Measured: Blood samples will be collected at following time points: prior to IP administration; 1.5; 3; 4.5; 6; 24; 96; 168; 336 and 504 hours after inject drug cycle 1

  4. Pharmacokinetic parameters: T1/2

    Half-life (T1/2)

    Measured: Blood samples will be collected at following time points: prior to IP administration; 1.5; 3; 4.5; 6; 24; 96; 168; 336 and 504 hours after inject drug cycle 1

  5. Rate of AE and SAE occurence

    Frequency of adverse events, including clinical examination, vital signs and laboratory tests.

    Measured: up to 128 days (6 cycles - each cycle is 21 days)

Timeline

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

  1. First posted29 Mar 2022
  2. Study start27 May 2019
  3. Primary completion31 Aug 2020
  4. Study completion19 Feb 2021

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two group: study drug and reference
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05301530
Sponsor's protocol ID
NNG17.1
Status last verified
Mar 2022
First submitted
8 Jun 2020
Last updated
29 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Các liệu pháp nhắm trúng đích nở rộ, Nguyễn Chấn Hùng và cộng sự, Tạp chí Ung thư học Việt Nam, số 4 - 2013

  • Bell R. What can we learn from Herceptin trials in metastatic breast cancer? Oncology. 2002;63 Suppl 1:39-46. doi: 10.1159/000066200.

    PubMed 12422054

  • Hamberg P, Bos MM, Braun HJ, Stouthard JM, van Deijk GA, Erdkamp FL, van der Stelt-Frissen IN, Bontenbal M, Creemers GJ, Portielje JE, Pruijt JF, Loosveld OJ, Smit WM, Muller EW, Schmitz PI, Seynaeve C, Klijn JG; Dutch Breast Cancer Trialists' Group (BOOG). Randomized phase II study comparing efficacy and safety of combination-therapy trastuzumab and docetaxel vs. sequential therapy of trastuzumab followed by docetaxel alone at progression as first-line chemotherapy in patients with HER2+ metastatic breast cancer: HERTAX trial. Clin Breast Cancer. 2011 Apr;11(2):103-13. doi: 10.1016/j.clbc.2011.03.003. Epub 2011 Apr 11.

    PubMed 21569996

  • Bullock K, Blackwell K. Clinical efficacy of taxane-trastuzumab combination regimens for HER-2-positive metastatic breast cancer. Oncologist. 2008 May;13(5):515-25. doi: 10.1634/theoncologist.2007-0204.

    PubMed 18515736

  • Slamon DJ, Romond EH, Perez EA; CME Consultants, Inc. Advances in adjuvant therapy for breast cancer. Clin Adv Hematol Oncol. 2006 Mar;4(3 Suppl 7):suppl 1, 4-9; discussion suppl 10; quiz 2 p following suppl 10.

    PubMed 16736568

  • Polychemotherapy for early breast cancer: an overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group. Lancet. 1998 Sep 19;352(9132):930-42.

    PubMed 9752815

  • Gennari A, Conte P, Rosso R, Orlandini C, Bruzzi P. Survival of metastatic breast carcinoma patients over a 20-year period: a retrospective analysis based on individual patient data from six consecutive studies. Cancer. 2005 Oct 15;104(8):1742-50. doi: 10.1002/cncr.21359.

    PubMed 16149088

  • Hynes NE, Stern DF. The biology of erbB-2/neu/HER-2 and its role in cancer. Biochim Biophys Acta. 1994 Dec 30;1198(2-3):165-84. doi: 10.1016/0304-419x(94)90012-4. No abstract available.

    PubMed 7819273

  • Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987 Jan 9;235(4785):177-82. doi: 10.1126/science.3798106.

    PubMed 3798106

  • Slamon DJ, Godolphin W, Jones LA, Holt JA, Wong SG, Keith DE, Levin WJ, Stuart SG, Udove J, Ullrich A, et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science. 1989 May 12;244(4905):707-12. doi: 10.1126/science.2470152.

    PubMed 2470152

  • Press MF, Bernstein L, Thomas PA, Meisner LF, Zhou JY, Ma Y, Hung G, Robinson RA, Harris C, El-Naggar A, Slamon DJ, Phillips RN, Ross JS, Wolman SR, Flom KJ. HER-2/neu gene amplification characterized by fluorescence in situ hybridization: poor prognosis in node-negative breast carcinomas. J Clin Oncol. 1997 Aug;15(8):2894-904. doi: 10.1200/JCO.1997.15.8.2894.

    PubMed 9256133

  • Herceptin [package insert] Roche Inc; 2010

  • Marty M, Cognetti F, Maraninchi D, Snyder R, Mauriac L, Tubiana-Hulin M, Chan S, Grimes D, Anton A, Lluch A, Kennedy J, O'Byrne K, Conte P, Green M, Ward C, Mayne K, Extra JM. Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group. J Clin Oncol. 2005 Jul 1;23(19):4265-74. doi: 10.1200/JCO.2005.04.173. Epub 2005 May 23.

    PubMed 15911866

  • Meden H, Beneke A, Hesse T, Novophashenny I, Wischnewsky M. Weekly intravenous recombinant humanized anti-P185HER2 monoclonal antibody (herceptin) plus docetaxel in patients with metastatic breast cancer: a pilot study. Anticancer Res. 2001 Mar-Apr;21(2B):1301-5.

    PubMed 11396203

  • Plosker GL, Keam SJ. Trastuzumab: a review of its use in the management of HER2-positive metastatic and early-stage breast cancer. Drugs. 2006;66(4):449-75. doi: 10.2165/00003495-200666040-00005.

    PubMed 16597163

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Faceptor, Herceptin and Docetaxel in people with Breast Cancer Metastatic and Breast Cancer Female, run by Nanogen Pharmaceutical Biotechnology Joint Stock Company at 2 sites in Vietnam.

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 11 inclusion and 11 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 29 Mar 2022. 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 Vietnam. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Pharmacokinetic parameters: Cmax (time frame: Blood samples will be collected at following time points: prior to IP administration; 1.5; 3; 4.5; 6; 24; 96; 168; 336 and 504 hours after inject drug cycle 1). 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 NCT05301530, which also lists 31 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 29 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in