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Early Breast CancerPhase 3NCT02187744

A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)

A Phase 3 study testing PF-05280014, Taxotere® and Paraplatin® in people with Early Breast Cancer, run by Pfizer at 52 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

The current study will compare PK, efficacy, safety, and immunogenicity of PF-05280014 (Trastuzumab-Pfizer) in combination with Taxotere® and Carboplatin (Paraplatin) versus Herceptin® (Trastuzumab-EU) approved in the EU in combination with Taxotere® and Carboplatin (Paraplatin) in patients with operable HER2… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Early Breast Cancer
What is being tested?
PF-05280014, Taxotere® and Paraplatin®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
52 sitesin 10 countries
Study dates
23 Sep 2014to 9 Mar 2016
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 HER2 overexpressing invasive breast cancer.
  • Plan for definitive surgical resection of breast tumor (i.e., lumpectomy or mastectomy, and sentinel node (SN) biopsy or axillary lymph node dissection (ALND).
  • Plan for neoadjuvant chemotherapy.
  • Measurable disease in the breast after diagnostic biopsy, defined as longest diameter ≥ 2.0 cm.

Who cannot join

  • Bilateral breast cancer.
  • Inflammatory breast cancer.
  • Presence of known distant metastases.
  • Received prior treatment, including chemotherapy, endocrine therapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer.

Trial locations and contacts

52 sites in 10 countries.

52 sites in 10 countries

Russia19 sites

  • SBHI "Regional Oncology Dispensary"

    Irkutsk, 664035

  • Regional Budgetary Healthcare Institution "Kursk regional clinical oncological Dispensary"

    Kislino Settlement, Ryshkovskiy Village Council, 305524

  • Regional Budgetary Healthcare Institution

    Kursk, 305035

  • State Budgetary Healthcare Institution "Leningrad Regional Oncological Dispensary"

    Kuzmolovo, Leningradskaya Oblast', 188663

  • FSBI "Russian Oncology Scientific center n.a. N. N. Blokhin" RAMS

    Moscow, 115478

  • State Budgetary Institution Of Healthcare

    Moscow, 129301

  • SBHI of NNR "Clinical diagnostic center"

    Nizhny Novgorod, 603006

  • State Budgetary Healthcare Institution of NNR "Nizhniy Novgorod Regional Oncological Dispensary"

    Nizhny Novgorod, 603081

  • Budgetary Institution of healthcare of Omsk region "Clinical oncological dispensary"

    Omsk, 644046

  • "State Budgetary Healthcare Institution of Stavropol Region ""Pyatigorsk Oncological Dispensary"""

    Pyatigorsk, Stavropol Kray, 357502

  • State Budgetary Educational Institution of Higher Professional Education "North-Western State

    Saint Petersburg, 195067

  • Saint-Peterbsurg Clinical Oncological dispensary of Moscow district

    Saint Petersburg, 196247

  • Saint-Petersburg State Budgetary Healthcare Institution "Oncological Dispensary of Moscow District"

    Saint Petersburg, 196247

  • LLC RAMSAY Diagnostic RUS

    Saint Petersburg, 197046

  • "Federal State Institution ""Scientific Research Institute of Oncology n.a. N.N.Petrov""

    Saint Petersburg, 197758

  • Saint-Petersburg State Budgetary Institution of healthcare "City Clinical Oncological Dispensary"

    Saint Petersburg, 198255

  • "State Budgetary Healthcare Institution ""Republican Clinical Oncological Dispensary of the Ministry

    Ufa, Republic Bashkortost, 450054

  • SRBHI "Regional Clinical Oncology Dispensary"

    Velikiy Novgorod, 173023

  • State Budgetary Healthcare Institution "Volgograd Regional Oncological Dispensary #3"

    Volzhsky, Volgograd Oblast, 404130

Other trials in Russia

Ukraine10 sites

  • Municipal Healthcare Institution 'Chernihiv Regional Oncology Dispensary', Mamology Department

    Chernihiv, 14029

  • MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC', Dep.-nt of Chemotherapy;

    Dnipropetrovsk, 49102

  • SI "Institute of Medical Radiology n.a.S.P. Hrygoriev of National Academy

    Kharkiv, 61024

  • Munincipal Healthcare Institution"Kharkiv Regional Clinical Oncologic Center

    Kharkiv, 61070

  • Khmelnytskyi Regional Oncologic Dispensary

    Khmelnytskyi, 29009

  • MI 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council'

    Kryvyi Rih, 50048

  • Lviv State Oncologic Regional Treatment and Diagnostic Center

    Lviv, 79031

  • Municipal Institution 'Odesa Regional Clinical Hospital', Mamology Center

    Odesa, 65025

  • Regional Municipal Institution "Sumy Regional Clinical Oncology Dispensary", Thoracic Department

    Sumy, 40005

  • Vinnytsia Regional Oncology Clinical Dispensary, Chemotherapy Department

    Vinnytsia, 21029

Other trials in Ukraine

Hungary6 sites

  • Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz. Belgyogyaszati Klinika Onkologiai Reszleg

    Budapest, 1083

  • Szent Imre Egyetemi Oktato Korhaz

    Budapest, 1115

  • Uzsoki Utcai Korhaz, Onkoradiologia, Sugarterapia Fovarosi Onkoradiologiai Kozpont

    Budapest, 1145

  • Bacs-Kiskun Megyei Korhaz

    Kecskemét, Bács-Kiskun county, 6000

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktatokorhaz,

    Miskolc, 3526

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet

    Szolnok, 5000

Other trials in Hungary

United States4 sites

  • Compassionate Cancer Care Medical Group, Inc.

    Fountain Valley, California, 92708

  • Millennium Oncology (Imaging Facility)

    Kingwood, Texas, 77339

  • Millennium Oncology (Imaging Facility)

    Shenandoah, Texas, 77380

  • Millennium Oncology

    Shenandoah, Texas, 77384

Other trials in United States

Italy4 sites

  • Division of Medical Senology

    Milan, MI, 20141

  • Divisione di Oncologia Medica B

    Roma, RM, 00144

  • IRCCS Istituto Nazionale Tumori Regina Elena (IRE)

    Roma, RM, 00144

  • Dept. of Surgery

    Roma, RM, 00168

Other trials in Italy

Poland3 sites

  • Szpitale Wojewodzkie w Gdyni Sp. z o.o., Oddzial Onkoligii i Radioterapii

    Gdynia, 81-519

  • Oddzial Chorob Rozrostowych

    Lodz, 93-513

  • SPZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

    Olsztyn, 10-228

Other trials in Poland

Slovakia3 sites

  • Onkologicky ustav sv. Alzbety, s.r.o.

    Bratislava, 812 50

  • Narodny Onkologicky ustav

    Bratislava, 833 10

  • Vychodoslovensky onkologicky ustav, a.s.

    Košice, 04191

Other trials in Slovakia

Belarus1 site

  • SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'

    Lyasny, Minsk Oblast, 223040

Other trials in Belarus

Czechia1 site

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

Other trials in Czechia

Serbia1 site

  • Institute For Oncology And Radiology Of Serbia

    Belgrade, 11000

Other trials in Serbia

About this study

Official title: A RANDOMIZED, DOUBLE-BLIND PHARMACOKINETIC STUDY OF PF-05280014 PLUS TAXOTERE (REGISTERED) AND CARBOPLATIN VERSUS HERCEPTIN (REGISTERED) PLUS TAXOTERE (REGISTERED) AND CARBOPLATIN FOR THE NEOADJUVANT TREATMENT OF PATIENTS WITH OPERABLE HER2-POSITIVE BREAST CANCER

The current study will compare PK, efficacy, safety, and immunogenicity of PF-05280014 (Trastuzumab-Pfizer) in combination with Taxotere® and Carboplatin (Paraplatin) versus Herceptin® (Trastuzumab-EU) approved in the EU in combination with Taxotere® and Carboplatin (Paraplatin) in patients with operable HER2 positive, breast cancer in the neoadjuvant setting. The hypothesis to be tested in this study is the percentage of patients with steady state Cycle 5 Ctrough (Cycle 6 pre-dose) >20 µg/mL of trastuzumab-Pfizer is similar to EU-approved trastuzumab, using a margin of -12.5%.

Being tested
PF-05280014, Taxotere®, Paraplatin®, Trastuzumab-EU
Keywords
Biosimilars, Non-inferiority, Neoadjuvant Setting, Early Breast Cancer, PK, Phase 3, Trastuzumab, Herceptin, HER2 Positive
Medical subject headings
Breast Neoplasms

What participants receive

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

  • PF-05280014Biological

    Concentrate for solution for infusion, sterile vial 150 mg, Day 1 Cycle 1 will be a loading dose of 8 mg/kg infused over 90 minutes. Subsequent infusions will follow every 3 weeks (i.e., cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability, maximum of 6 cycles.

  • Taxotere®Drug

    Also called docetaxel

    Injection concentrate single-dose vials containing 20 mg (0.5 mL) or 80 mg (2 mL), each mL contains 40 mg docetaxel (anhydrous) and 1040 mg polysorbate 80, The starting dose of Taxotere® (docetaxel) will be 75 mg/m2 administered intravenously over 60 minutes every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.

  • Paraplatin®Drug

    Also called carboplatin

    Lyophilized powder, single-dose vials containing 50 mg, 150 mg, and 450 mg of Carboplatin for administration by intravenous infusion (each vial contains equal parts by weight of Carboplatin and mannitol), starting dose 6 AUC, over 15 minutes or longer every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.

  • Trastuzumab-EUBiological

    Concentrate for solution for infusion, sterile vial 150 mg, Day 1 Cycle 1 will be a loading dose of 8 mg/kg infused over 90 minutes. Subsequent infusions will follow every 3 weeks (i.e., cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability, maximum 6 cycles.

  • Taxotere®Drug

    Also called docetaxel

    Injection concentrate single-dose vials containing 20 mg (0.5 mL) or 80 mg (2 mL), each mL contains 40 mg docetaxel (anhydrous) and 1040 mg polysorbate 80, The starting dose of Taxotere® (docetaxel) will be 75 mg/m2 administered intravenously over 60 minutes every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.

  • Paraplatin®Drug

    Also called carboplatin

    Lyophilized powder, single-dose vials containing 50 mg, 150 mg, and 450 mg of Carboplatin for administration by intravenous infusion (each vial contains equal parts by weight of Carboplatin and mannitol), starting dose 6 AUC, over 15 minutes or longer every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.

Study groups in NCT02187744
Study groupRoleWhat they receive
PF-05280014ExperimentalNot described
Receives: Biological: PF-05280014; Drug: Taxotere®; Drug: Paraplatin®
Herceptin®Active comparatorNot described
Receives: Biological: Trastuzumab-EU; Drug: Taxotere®; Drug: Paraplatin®

What is being measured

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

  1. Percentage of Participants With Steady State Drug Concentration Ctrough (Cycle 6 Pre-dose) >20 µg/mL at Cycle 5.

    The percentage of participants with Cycle 5 Ctrough (Cycle 6 pre-dose) >20 μg/mL in each treatment group, the denominator being the number of participants in the per protocol population for each treatment group.

    Measured: Cycle 5

Secondary outcomes (5)

  1. Mean Predose Trastuzumab-Pfizer and Trastuzumab-EU Concentrations at Cycles 1 Through 6.

    Samples of blood were taken pre-dose on Cycles 1, 2, 4, 5, and 6, and at 1 hour post dose on Cycles 1 and 5 for pharmacokinetic evaluation.

    Measured: Cycles 1 through 6

  2. Pathologic Complete Response (pCR) Defined as the Absence of Invasive Neoplastic Cells in the Breast and Lymph Nodes.

    Following surgery after treatment completion, tumors were assessed as Complete Pathological Response, Partial Pathological Response, or No Pathological Response.

    Measured: Cycle 6/End of treatment

  3. Objective Response Rate (ORR) Defined as the Percentage of Participants Having Complete or Partial Response at End of Treatment, Based on Radiographic Assessments of the Tumor.

    ORR was defined as Complete Response (CR), Partial Response (PR), Stable (SD), Progressive Disease (PD) or Indeterminate (IND). ORR was the percentage of participants who had CR or PR at Cycle 6/End of treatment.

    Measured: Cycle 6/End of treatment

  4. Incidence of Anti-trastuzumab Antibodies (ADAs) at Cycles 1 Through 6.

    The number of participants with positive (titer >=1.00) pre-dose ADA samples, participants counted towards the total if for at least one sample, the ADA was positive.

    Measured: Cycles 1 through 6

  5. Incidence of Neutralizing Antibodies (NAb) at Cycles 1 Through 6.

    The number of participants with positive (NAb response >=1.48) pre-dose NAb samples, participants counted towards the total if for at least one sample, the NAb was positive.

    Measured: Cycles 1 through 6

Timeline

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

  1. First posted11 Jul 2014 (estimated)
  2. Study start23 Sep 2014
  3. Primary completion9 Mar 2016
  4. Study completion9 Mar 2016

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02187744
Sponsor's protocol ID
B3271004
Other IDs
REFLECTIONS B327-04, 2013-004679-11, REFLECTIONS (B327-04)
Status last verified
Dec 2018
First submitted
30 Jun 2014
Last updated
8 Jan 2019
Data monitoring committee
Yes
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Lammers PE, Dank M, Masetti R, Abbas R, Hilton F, Coppola J, Jacobs I. Neoadjuvant PF-05280014 (a potential trastuzumab biosimilar) versus trastuzumab for operable HER2+ breast cancer. Br J Cancer. 2018 Aug;119(3):266-273. doi: 10.1038/s41416-018-0147-1. Epub 2018 Jul 13.

    PubMed 30002437

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PF-05280014, Taxotere® and Paraplatin® in people with Early Breast Cancer, run by Pfizer at 52 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 4 inclusion and 4 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 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in Russia, Ukraine, Hungary, United States, Italy 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 7 Apr 2017). 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?

Percentage of Participants With Steady State Drug Concentration Ctrough (Cycle 6 Pre-dose) >20 µg/mL at Cycle 5. (time frame: Cycle 5). 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 NCT02187744, which also lists 1 linked publication.

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 8 Jan 2019.

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