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Breast CancerPhase 3NCT03556358

Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer

A Phase 3 study testing TX05 (trastuzumab), Herceptin® and Paclitaxel in people with Breast Cancer and Breast Neoplasms, run by Tanvex BioPharma USA, Inc. at 146 sites in 10 countries.

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

This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
TX05 (trastuzumab), Herceptin® and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
809 participants
Where
146 sitesin 10 countries
Study dates
28 Jun 2018to 4 Feb 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed HER 2 overexpressing invasive primary operable Stage II/IIIa breast cancer (AJCC version 7 staging criteria).
  • Available tumor tissue for central review of HER2 status.
  • Planned surgical resection of breast tumor.
  • Planned neoadjuvant chemotherapy.
  • Documentation of HER2 gene amplification or overexpression.
  • Ipsilateral, measurable tumor longest diameter > 2 cm.
Show all 11Show fewer
  • Known estrogen receptor (ER) and progesterone receptor (PR) hormone status (may be performed during screening).
  • ECOG performance status of 0 or 1.
  • Adequate bone marrow, hepatic and renal functions.
  • Left ventricular ejection fraction (LVEF) ≥ 50% or within institutional normal limits, measured by echocardiography or MUGA scan.
  • Effective contraception as defined by protocol.

Who cannot join

  • Investigational therapy within 2 months of first dose of study drug.
  • Bilateral breast cancer.
  • Inflammatory breast cancer
  • Metastases.
  • Prior chemotherapy, biologic therapy, radiation or surgery for any active malignancy, including breast cancer.
  • Cardiac insufficiency, myocardial infarction, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, unstable angina pectoris, uncontrolled arrhythmia or pulmonary embolus within the previous 12 months prior to 1st administration of study drug.
Show all 14Show fewer
  • Clinically significant active infection, poorly controlled diabetes mellitus and/or uncontrolled hypertension.
  • Major surgery, significant traumatic injury, radiation therapy and/or grade 3 hemorrhage within 4 weeks of 1st administration of study drug.
  • Pre-existing clinically significant Grade 2 peripheral neuropathy.
  • Malignancy within the last 5 years (except squamous/basal cell carcinoma of the skin, cervical carcinoma in situ and superficial bladder cancer).
  • Severe dyspnea at rest requiring oxygen therapy.
  • Known positive HIV, acute or chronic active infection with Hepatitis B or Hepatitis C.
  • Current pregnancy or breastfeeding.
  • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in normal range despite optimal therapy.

Trial locations and contacts

146 sites in 10 countries.

146 sites in 10 countries

Russia35 sites

  • Tanvex Investigational Site 1535

    Arkhangelsk, 163045

  • Tanvex Investigational Site 1531

    Belgorod, 308010

  • Tanvex Investigational Site 1538

    Chelyabinsk, 454048

  • Tanvex Investigational Site 1520

    Ivanovo, 153040

  • Tanvex Investigational Site 1515

    Izhevsk, 426009

  • Tanvex Investigational Site 1502

    Kaluga, 248007

  • Tanvex Investigational Site 1540

    Kazan', 420029

  • Tanvex Investigational Site 1529

    Krasnodar, Krasnodarskiy Kray, 350040

  • Tanvex Investigational Site 1512

    Krasnoyarsk, 660133

  • Tanvex Investigational Site 1505

    Kursk, 305035

  • Tanvex Investigational Site 1530

    Moscow, 121467

  • Tanvex Investigational Site 1536

    Moscow, 125284

  • Tanvex Investigational Site 1514

    Moscow, 129128

  • Tanvex Investigational Site 1507

    Moscow, 129515

  • Tanvex Investigational Site 1511

    Novosibirsk, Siberia, 630099

  • Tanvex Investigational Site 1509

    Omsk, Omsk Oblast, 644013

  • Tanvex Investigational Site 1503

    Omsk, 644013

  • Tanvex Investigational Site 1537

    Orenburg, 460021

  • Tanvex Investigational Site 1510

    Pushkin, Sankt-Peterburg, 196603

  • Tanvex Investigational Site 1519

    Pyatigorsk, Stavropol Kray, 357502

  • Tanvex Investigational Site 1521

    Rostov-on-Don, 344037

  • Tanvex Investigational Site 1516

    Saint Petersburg, 191015

  • Tanvex Investigational Site 1517

    Saint Petersburg, 191025

  • Tanvex Investigational Site 1523

    Saint Petersburg, 191104

  • Tanvex Investigational Site 1524

    Saint Petersburg, 195271

  • Tanvex Investigational Site 1525

    Saint Petersburg, 196247

  • Tanvex Investigational Site 1506

    Saint Petersburg, 197758

  • Tanvex Investigational Site 1526

    Saint Petersburg, 197758

  • Tanvex Investigational Site 1501

    Saint Petersburg, 198255

  • Tanvex Investigational Site 1508

    Saransk, 430032

  • Tanvex Investigational Site 1513

    Sochi, Krasnodarskiy Kray, 354057

  • Tanvex Investigational Site 1518

    Tomsk, Tomsk Oblast, 634050

  • Tanvex Investigational Site 1533

    Tomsk, 634009

  • Tanvex Investigational Site 1522

    Ufa, Bashkortostan Republic, 450054

  • Tanvex Investigational Site 1534

    Yaroslavl, 150054

Other trials in Russia

India27 sites

  • Tanvex Invesitgational Site 7033

    Ahmedabad, 380016

  • Tanvex Investigational Site 7019

    Bangalore, 560027

  • Tanvex Investigational Site 7037

    Bangalore, 560072

  • Tanvex Investigational Site 7022

    Belagavi, 590010

  • Tanvex Investigational Site 7002

    Bikaner, Rajasthan, 334003

  • Tanvex Investigational Site 7034

    Chandigarh, 160012

  • Tanvex Investigational Site 7013

    Coimbatore, 641037

  • Tanvex Investigational Site 7024

    Gūrgaon, 122001

  • Tanvex Investigational Site 7045

    Hyderabad, 500004

  • Tanvex Investigational Site 7036

    Hyderabad, 500034

  • Tanvex Investigational Site 7009

    Jaipur, 302004

  • Tanvex Investigational Site 7039

    Kolkata, 700014

  • Tanvex Investigational Site 7040

    Kolkata, 700094

  • Tanvex Investigational Site 7006

    Kolkata, 700099

  • Tanvex Investigational Site 7005

    Lucknow, 226003

  • Tanvex Investigational Site 7010

    Madurai, Tamil Nadu, 625107

  • Tanvex Investigational Site 7012

    Manipal, 576104

  • Tanvex Investigational Site 7041

    Model Town, 141002

  • Tanvex Investigational Site 7031

    Nāka, 422004

  • Tanvex Investigational Site 7007

    Nashik, Maharashtra, 422005

  • Tanvex Investigational Site 7001

    Nashik, 422002

  • Tanvex Investigational Site 7015

    Pune, Maharashtra, 411001

  • Tanvex Investigational Site 7003

    Pune, Maharashtra, 411004

  • Tanvex Investigational Site 7004

    Pune, Maharashtra, 411004

  • Tanvex Investigational Site 7042

    Trichy, 620008

  • Tanvex Investigational Site 7018

    Vadodara, 390007

  • Tanvex Investigational Site 7017

    Vijayawada, 520002

Other trials in India

Ukraine19 sites

  • Tanvex Investigational Site 1808

    Chernihiv, 14029

  • Tanvex Investigational Site 1821

    Chernivtsi, 58013

  • Tanvex Investigational Site 1803

    Dnipro, 49102

  • Tanvex Investigational Site 1824

    Dnipro, 49600

  • Tanvex Investigational Site 1820

    Kherson, 73000

  • Tanvex Investigational Site 1812

    Khmelnytskyi, 29000

  • Tanvex Investigational Site 1815

    Kiev, 03022

  • Tanvex Investigational Site 1811

    Kiev, 03115

  • Tanvex Investigational Site 1802

    Kiev, 04107

  • Tanvex Investigational Site 1814

    Kropyvnytskyi, 25000

  • Tanvex Investigational Site 1819

    Kropyvnytskyi, 25006

  • Tanvex Investigational Site 1804

    Kryvyi Rih, 50048

  • Tanvex Investigational Site 1809

    Kyiv, 03126

  • Tanvex Investigational Site 1810

    Odesa, 65055

  • Tanvex Investigational Site 1806

    Sumy, 40022

  • Tanvex Investigational Site 1822

    Ternopil, 46023

  • Tanvex Investigational Site 1823

    Uzhhorod, 88000

  • Tanvex Investigational Site 1818

    Vinnitsya, 21029

  • Tanvex Investigational Site 1813

    Zaporizhzhya, 69104

Other trials in Ukraine

Mexico14 sites

  • Tanvex Investigational Site 2117

    Aguascalientes, 20127

  • Tanvex Investigational Site 2109

    Aguascalientes, 20234

  • Tanvex Investigational Site 2116

    Cancún, 77506

  • Tanvex Investigational Site 2104

    Cuauhtémoc, 06100

  • Tanvex Investigational Site 2114

    Cuauhtémoc, 06760

  • Tanvex Investigational Site 2101

    Cuautitlán Izcalli, 54769

  • Tanvex Investigational Site 2113

    México, 06100

  • Tanvex Investigational Site 2111

    Mexico City, 06760

  • Tanvex Investigational Site 2102

    Monterrey, Nuevo León, 64000

  • Tanvex Investigational Site 2103

    Monterrey, 64320

  • Tanvex Investigational Site 2106

    Oaxaca City, 68000

  • Tanvex Investigational Site 2112

    San Luis Potosí City, 78200

  • Tanvex Investigational Site 2110

    Tequisquiapan, 76750

  • Tanvex Investigational Site 2108

    Zapopan, 45030

Other trials in Mexico

Georgia13 sites

  • Tanvex Investigational Site 5006

    Batumi, 6000

  • Tanvex Investigational Site 5002

    Batumi, 6010

  • Tanvex Investigational Site 5003

    Tbilisi, 0144

  • Tanvex Investigational Site 5001

    Tbilisi, 0159

  • Tanvex Investigational Site 5005

    Tbilisi, 0159

  • Tanvex Investigational Site 5012

    Tbilisi, 0159

  • Tanvex Investigational Site 5013

    Tbilisi, 0177

  • Tanvex Investigational Site 5004

    Tbilisi, 0179

  • Tanvex Investigational Site 5010

    Tbilisi, 0186

  • Tanvex Investigational Site 5011

    Tbilisi, 0186

  • Tanvex Investigational Site 5008

    Tbilisi, 112

  • Tanvex Investigational Site 5009

    Tbilisi, 131

  • Tanvex Investigational Site 5007

    Tbilisi, 141

Other trials in Georgia

Philippines12 sites

  • Tanvex Investigational Site 1206

    Bacolod City, Negros Occidental, 6100

  • Tanvex Investigational Site 1203

    Cebu City, Cebu, 6000

  • Tanvex Investigational Site 1204

    Cebu City, Cebu, 6000

  • Tanvex Investigational Site 1211

    Cebu City, Cebu, 6000

  • Tanvex Investigational Site 1212

    Davao City, 8000

  • Tanvex Investigational Site 1214

    Makati City, 1229

  • Tanvex Investigational Site 1207

    Manila, National Capital Region, 1000

  • Tanvex Investigational Site 1201

    Manila, 1000

  • Tanvex Investigational Site 1208

    Quezon City, Manila, 1110

  • Tanvex Investigational Site 1209

    Quezon City, 1101

  • Tanvex Investigational Site 1213

    Quezon City, 1102

  • Tanvex Investigational Site 1210

    Santo Tomas, Batangas, 4234

Other trials in Philippines

Peru11 sites

  • Tanvex Investigational Site 1101

    Arequipa, 04001

  • Tanvex Investigational Site 1107

    Arequipa, 04001

  • Tanvex Investigational Site 1104

    Chiclayo, Lambayeque, 14001

  • Tanvex Investigational Site 1110

    Lima, 15046

  • Tanvex Investigational Site 1112

    Lima Cercado, Lima region, 15082

  • Tanvex Investigational Site 1108

    San Borja, Lima region, 15036

  • Tanvex Investigational Site 1113

    San Borja, Lima region, 15036

  • Tanvex Investigational Site 1105

    San Isidro, 15036

  • Tanvex Investigational Site 1102

    San Isidro, 15073

  • Tanvex Investigational Site 1109

    Surquillo, 15038

  • Tanvex Investigational Site 1103

    Trujillo, 13001

Other trials in Peru

Belarus7 sites

  • Tanvex Investigational Site 1007

    Babruysk, Mogilyov Oblast, 213825

  • Tanvex Investigational Site 1006

    Grodno, 230017

  • Tanvex Investigational Site 1003

    Homyel, 246012

  • Tanvex Investigational Site 1008

    Lyasny, Minsk Oblast, 223040

  • Tanvex Investigational Site 1002

    Minsk, 220013

  • Tanvex Investigational Site 1005

    Mogilev, 2120018

  • Tanvex Investigational Site 1001

    Vitebsk, 21008

Other trials in Belarus

Hungary6 sites

  • Tanvex Investigational Site 6003

    Budapest, 1122

  • Tanvex Investigational Site 6007

    Budapest, 1122

  • Tanvex Investigational Site 6005

    Debrecen, 4032

  • Tanvex Investigational Site 6006

    Győr, 9024

  • Tanvex Investigational Site 6004

    Miskolc, 3526

  • Tanvex Investigational Site 6001

    Pécs, 7264

Other trials in Hungary

Chile2 sites

  • Tanvex Investigational Site 4001

    Temuco, 4810469

  • Tanvex Investigational Site 4002

    Viña del Mar, 2520598

Other trials in Chile

About this study

Official title: A Randomized, Double-blind, Parallel Group, Phase III Trial to Compare the Efficacy, Safety, and Immunogenicity of TX05 With Herceptin® in Subjects With HER2 Positive Early Breast Cancer

This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.

Being tested
TX05 (trastuzumab), Herceptin®, Paclitaxel, Epirubicin, Cyclophosphamide
Keywords
trastuzumab, Herceptin
Medical subject headings
Breast Neoplasms

What participants receive

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

  • TX05 (trastuzumab)Biological

    8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)

  • Herceptin®Biological

    8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)

  • PaclitaxelDrug

    Also called Ribotax

    175 mg/m^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)

  • EpirubicinDrug

    75 mg/m^2, IV bolus infusion, every 3 weeks (Cycles 1-4)

  • CyclophosphamideDrug

    600 mg/m^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)

Study groups in NCT03556358
Study groupRoleWhat they receive
TX05 (trastuzumab)Experimental• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles Followed by: • IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
Receives: Biological: TX05 (trastuzumab); Drug: Paclitaxel; Drug: Epirubicin; Drug: Cyclophosphamide
Herceptin®Active comparator• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles Followed by: • IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
Receives: Biological: Herceptin®; Drug: Paclitaxel; Drug: Epirubicin; Drug: Cyclophosphamide

What is being measured

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

  1. Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR)

    Pathologic complete response was determined by central review and defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled lymph nodes following neoadjuvant systemic therapy (ypT0/Tis ypN0).

    Measured: 3-7 weeks following last dose of study treatment

Secondary outcomes (1)

  1. Objective Response Rate (ORR)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (ORR) = CR + PR.

    Measured: End of Treatment (Week 24) or Early Termination Visit

Timeline

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

  1. First posted14 Jun 2018
  2. Study start28 Jun 2018
  3. Primary completion27 Nov 2020
  4. Study completion4 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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
809 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03556358
Sponsor's protocol ID
TX05-03
Status last verified
Jan 2022
First submitted
1 Jun 2018
Last updated
14 Jan 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TX05 (trastuzumab), Herceptin® and Paclitaxel in people with Breast Cancer and Breast Neoplasms, run by Tanvex BioPharma USA, Inc. at 146 sites in 10 countries.

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 14 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 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 146 sites in Russia, India, Ukraine, Mexico, Georgia and 5 more countries. 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?

Yes. Results are posted in the registry (first posted 14 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR) (time frame: 3-7 weeks following last dose of study treatment). 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 NCT03556358.

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 14 Jan 2022.

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