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Breast Cancer MetastaticPhase 3NCT05301010

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

A Phase 3 study testing Faceptor, Herceptin and Docetaxel in people with Breast Cancer Metastatic and Breast Cancer Recurrent, 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
128 participants
Where
2 sitesVietnam
Study dates
2 Feb 2018to 19 Feb 2021
Phase
Phase 3
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)
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  • 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 Efficacy and 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 128 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

Primany endpoints is Overall Response Rate (ORR) according to RECIST 1.1. ORR includes Complete Response Rate and Partial Response Rate. ORR will be independently evaluated by an Independent Tumor Evaluation Board (ITEB).

This trial is intended to assess the biosimilarity of efficacy and safety between NNG-TMAB (Trastuzumab) and Herceptin® in combination with Docetaxel on recurrent or metastatic breast cancer patients with positive HER2.

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 Trastazumab

    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 NCT05301010
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. Overall Response Rate (ORR) according to RECIST 1.1 after 6 cycles

    ORR includes Complete Response Rate and Partial Response Rate. ORR will be independently evaluated by an Independent Tumor Evaluation Board (ITEB).

    Measured: at the end of cycle 6 (each cycle is 21 days)

  2. Overall Response Rate (ORR) according to RECIST 1.1 at the end of study

    ORR includes Complete Response Rate and Partial Response Rate. ORR will be independently evaluated by an Independent Tumor Evaluation Board (ITEB).

    Measured: baseline through end of study (up to 128 days)

Secondary outcomes (6)

  1. Progressive Disease Rate (PDR) according to RECIST 1.1

    Progressive Disease Rate (PDR). PDR will be independently evaluated by an Independent Tumor Evaluation Board (ITEB).

    Measured: PDR will be evaluated every 3 cycles (each cycle is 21 days) through the end of study (up to 128 days)

  2. Stable Disease Rate (SDR) according to RECIST 1.1

    Stable Disease Rate (SDR). SDR will be independently evaluated by an Independent Tumor Evaluation Board (ITEB).

    Measured: SDR will be evaluated every 3 cycles (each cycle is 21 days) through the end of study (up to 128 days)

  3. Progression-free survival (PFS) according to RECIST 1.1

    Progression-free survival (PFS) was defined as the time between the date patient signed the Informed Consent Form (ICF) and the date of disease progression or death from any cause.

    Measured: Baseline up to disease progression or death due to any cause, whichever occurs first (up to 128 days (6 cycles - each cycle is 21 days))

  4. Evaluate the patient's quality of life

    Quality of life of patients according to the EORTC QLQ-C30 questionnaire combined with EORTC QLQ-BR23 at week 24. All scores were linearly transformed to a 0 to 100 scale, according to international guidelines before assessment. A high or healthy level of functioning is represented by a high functional score. A high QOL is represented by a high score for global health status or QOL. More severe symptoms or problems are represented by high symptom scores or items.

    (i) EORTC QLQ-C30: is designed to measure cancer patients' physical, psychological and social functions.

    (ii) EORTC QLQ-BR23: is a breast-specific module that comprises of 23 questions.

    Measured: At week 24th

  5. Anti-drug antibody evaluation

    Percentage of participants with positive Anti-drug antibody

    Measured: At baseline,after 3 cycles of treatment, after 6 cycles of treatment (each cycle is 21 days)

  6. 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 start2 Feb 2018
  3. Primary completion19 Feb 2021
  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 3
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
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05301010
Sponsor's protocol ID
NNG17.2
Status last verified
Jan 2023
First submitted
17 Mar 2022
Last updated
27 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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

  • 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

  • Ahuja SP, Mehta SK. Incorporation of 2-14C-acetate into the lipids of various membranes from buffalo milk. Zentralbl Veterinarmed A. 1979 May;26(4):318-26. doi: 10.1111/j.1439-0442.1979.tb01762.x. No abstract available.

    PubMed 113962

  • 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

  • Meza-Junco J, Au HJ, Sawyer MB. Trastuzumab for gastric cancer. Expert Opin Biol Ther. 2009 Dec;9(12):1543-51. doi: 10.1517/14712590903439702.

    PubMed 19916733

  • Lara PN Jr, Chee KG, Longmate J, Ruel C, Meyers FJ, Gray CR, Edwards RG, Gumerlock PH, Twardowski P, Doroshow JH, Gandara DR. Trastuzumab plus docetaxel in HER-2/neu-positive prostate carcinoma: final results from the California Cancer Consortium Screening and Phase II Trial. Cancer. 2004 May 15;100(10):2125-31. doi: 10.1002/cncr.20228.

    PubMed 15139054

  • Tedesco KL, Thor AD, Johnson DH, Shyr Y, Blum KA, Goldstein LJ, Gradishar WJ, Nicholson BP, Merkel DE, Murrey D, Edgerton S, Sledge GW Jr. Docetaxel combined with trastuzumab is an active regimen in HER-2 3+ overexpressing and fluorescent in situ hybridization-positive metastatic breast cancer: a multi-institutional phase II trial. J Clin Oncol. 2004 Mar 15;22(6):1071-7. doi: 10.1200/JCO.2004.10.046.

    PubMed 15020608

  • [Study Results] Bines J, Murad A et al. (2003), Weekly docetaxel (Docetaxel) and trastuzumab (Herceptin) as primary therapy in stage III, HER2 overexpressing breast cancer - a Brazilian multicenter study. Breast cancer Res Treat, 82 (suppl 1):S56

  • Pivot X, Romieu G, Debled M, Pierga JY, Kerbrat P, Bachelot T, Lortholary A, Espie M, Fumoleau P, Serin D, Jacquin JP, Jouannaud C, Rios M, Abadie-Lacourtoisie S, Tubiana-Mathieu N, Cany L, Catala S, Khayat D, Pauporte I, Kramar A; PHARE trial investigators. 6 months versus 12 months of adjuvant trastuzumab for patients with HER2-positive early breast cancer (PHARE): a randomised phase 3 trial. Lancet Oncol. 2013 Jul;14(8):741-8. doi: 10.1016/S1470-2045(13)70225-0. Epub 2013 Jun 11.

    PubMed 23764181

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Faceptor, Herceptin and Docetaxel in people with Breast Cancer Metastatic and Breast Cancer Recurrent, 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 27 Feb 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Overall Response Rate (ORR) according to RECIST 1.1 after 6 cycles (time frame: at the end of cycle 6 (each cycle is 21 days)). 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 NCT05301010, which also lists 22 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 27 Feb 2023.

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