Breast CancerPhase 3EPHOS-BNCT01104571
Trastuzumab or Lapatinib Ditosylate in Treating Women With Early Breast Cancer
A Phase 3 study testing trastuzumab, lapatinib ditosylate and laboratory biomarker analysis in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial summary
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- trastuzumab, lapatinib ditosylate and laboratory biomarker analysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2010to Sep 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed (by core biopsy) invasive breast cancer
- Newly diagnosed disease
- Resectable disease
- HER2-positive disease, defined as 3+ measured by IHC or gene amplification by fluorescent in situ hybridization (FISH)
- No evidence of metastatic disease (T4 category) or suspicion of distant metastases
- No inflammatory breast cancer
- Planned surgery within 1 month of diagnosis, and willing to undergo adjuvant chemotherapy and trastuzumab post-surgery
- Must consent to donation of tissue and blood samples
- Hormone receptor status known
- Estrogen receptor-positive patients on hormone replacement therapy (HRT) must either continue HRT or must not have taken HRT within the past 3 weeks
- Estrogen receptor-negative patients may enter the trial whether or not they have taken HRT within the past 3 weeks
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Serum creatinine < 2 times upper limit of normal (ULN) OR creatinine clearance > 30 mg/dL
- Bilirubin < 2 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective non-hormonal contraception
- LVEF ≥ 55% by echocardiography or MUGA
- No clinically significant cardiac abnormalities or uncontrolled hypertension
- No prior myocardial infarction, heart failure, or significant angina
- No prior cancer at any other site that has been treated within the past 6 months (except basal cell carcinoma or cervical carcinoma in situ)
- No current active hepatic or biliary disease (except Gilbert syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease, per investigator assessment)
- No impaired gastrointestinal function that would sufficiently reduce lapatinib ditosylate absorption
- No known immediate or delayed hypersensitivity or reaction to drugs chemically related to trastuzumab or lapatinib ditosylate
- No altered mental state that would preclude obtaining written informed consent
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior trastuzumab (Herceptin®) therapy within the past 3 months
- No prior local cancer treatment (e.g., radiotherapy)
- No other concurrent investigational agent or anticancer therapy
- No use of herbal (alternative) therapies within 1 day of study entry (vitamin and/or mineral supplements allowed)
- No regular use of systemic steroids or other agents that could influence study endpoints (inhaled steroids allowed)
- No grapefruit and grapefruit juice for the duration of the study
- At least 14 days since prior and no concurrent CYP3A4 inducers
- At least 7 days since prior and no concurrent CYP3A4 inhibitors
- At least 6 months since prior and no concurrent amiodarone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Perioperative AntiHER-2 Therapy on Early Breast Cancer Study - Biological Phase (EPHOS-B)
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether trastuzumab or lapatinib ditosylate is more effective in treating women with early breast cancer.
Update June 2013:
Read more
Since the initial development of EPHOS-B in 2007 more evidence in relation to safety and efficacy of anti-HER2 therapies are now available, and in particular, a growing body of evidence that combinations of two anti-HER2 therapies are more effective than monotherapies. Therefore this study has been amended (PART 2) to a 1:1:2 ratio to control, perioperative trastuzumab or the combination of lapatinib and trastuzumab.
PURPOSE: This randomized phase III trial is studying trastuzumab to see how well it works compared with lapatinib ditosylate (and in since June 2013 - compared with a combination of lapatinib and trastuzumab) in treating women with early breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine whether pre-operative treatment of HER-2 positive breast cancer patients with anti-HER2 therapy consisting of trastuzumab (Herceptin®) vs lapatinib ditosylate inhibits proliferation or increases apoptosis.
- To compare the effects of trastuzumab (Herceptin®), lapatinib ditosylate and the combination of lapatinib ditosylate and trastuzumab (Herceptin®) on the inhibition of proliferation or increase of apoptosis
Secondary
- To determine whether pre-operative anti-HER2 treatment reduces serum angiogenic factors.
- To identify molecular predictors of biological response to anti-HER2 therapy
OUTLINE:
This is a multicenter study.Patients are stratified according to center. Patients are randomized to 1 of 3 treatment arms.
PART 1: From Protocol versions 1 to 4:
- Arm I (control): Patients receive no neoadjuvant or adjuvant therapy. Approximately 14 days after randomization, patients undergo either breast-conservation surgery or mastectomy.
- Arm II (trastuzumab [Herceptin®]): Patients receive neoadjuvant trastuzumab IV over 90 minutes on days 1 and 8. Approximately 11 days after beginning of neoadjuvant therapy, patients undergo either breast-conservation surgery or mastectomy, and receive adjuvant trastuzumab on day 15.
- Arm III (lapatinib ditosylate): Patients receive neoadjuvant oral lapatinib ditosylate once daily on days 1-11. Within 24 hours after completion of neoadjuvant therapy, patients undergo either breast-conservation surgery or mastectomy, and receive adjuvant lapatinib ditosylate once daily on days 12-28.
Patients also receive standard adjuvant systemic therapy, including endocrine therapy (for hormone-sensitive disease) and/or chemotherapy and radiotherapy.
PART 2: From Protocol Version 5 (June 2013)
- Arm I (control): Patients receive no neoadjuvant or adjuvant therapy. Approximately 14 days after randomization, patients undergo either breast-conservation surgery or mastectomy.
- Arm II (trastuzumab [Herceptin®]): Patients receive neoadjuvant trastuzumab IV over 90 minutes on days 1 and 8. Approximately 11 days after beginning of neoadjuvant therapy, patients undergo either breast-conservation surgery or mastectomy, and receive adjuvant trastuzumab on day 15.
- Arm III (lapatinib ditosylate and (trastuzumab [Herceptin®] combination): Patients receive oral lapatinib ditosylate once daily on days 1-11. Within 24 hours after completion of neoadjuvant therapy, patients undergo either breast-conservation surgery or mastectomy, and receive adjuvant lapatinib ditosylate once daily on days 12-28. Patients also receive neoadjuvant trastuzumab IV over 90 minutes on days 1 and 8 and receive adjuvant trastuzumab on day 15.
PART 1 and 2:
Patients also receive standard adjuvant systemic therapy, including endocrine therapy (for hormone-sensitive disease) and/or chemotherapy and radiotherapy.
All patients undergo blood and tissue sample collection periodically for biomarker research studies comprising biomarkers of proliferation, apoptosis, and angiogenesis.
After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 10 years.
Peer Reviewed and Funded by Cancer Research UK
- Conditions
- Breast Cancer
- Being tested
- trastuzumab, lapatinib ditosylate, laboratory biomarker analysis, adjuvant therapy, neoadjuvant therapy
- Keywords
- HER2-positive breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, estrogen receptor-negative breast cancer, estrogen receptor-positive breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumabBiological
Trastuzumab 6mg/kg iv given on days 1 \& 8 pre-surgery \& one dose of 2mg/kg iv between days 15-19 post surgery
lapatinib ditosylateDrug
Part 1: Lapatinib 1500mg/day p.o. continuously for 28 days. Should start 11 days (+2 or -1 day) before the scheduled surgery.
Part 2: Lapatinib 1000mg/day p.o. continuously for 28 days. Should start 11 days (+2 or -1 day) before the scheduled surgery.
laboratory biomarker analysisOther
adjuvant therapyProcedure or surgery
neoadjuvant therapyProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
therapeutic conventional surgery
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Control | Other | No peri-operative therapy given Receives: Other: laboratory biomarker analysis; Procedure: therapeutic conventional surgery |
| Part 1: Trastuzumab | Experimental | Trastuzumab 6mg/kg iv given on days 1 \& 8 pre-surgery \& one dose of 2mg/kg iv between days 15-19 post surgery. Receives: Biological: trastuzumab; Other: laboratory biomarker analysis; Procedure: adjuvant therapy; Procedure: neoadjuvant therapy |
| Part 1: lapatinib | Experimental | Lapatinib 1500mg/day p.o. continuously for 28 days. Should start 11 days (+2 or -1 day) before the scheduled surgery Receives: Drug: lapatinib ditosylate; Other: laboratory biomarker analysis; Procedure: adjuvant therapy; Procedure: neoadjuvant therapy |
| Part 2: Control | Other | No peri-operative therapy Receives: Other: laboratory biomarker analysis; Procedure: therapeutic conventional surgery |
| Part 2: Trastuzumab | Experimental | Trastuzumab 6mg/kg iv given on days 1 \& 8 pre-surgery \& one dose of 2mg/kg iv between days 15-19 post surgery. Receives: Biological: trastuzumab; Other: laboratory biomarker analysis; Procedure: adjuvant therapy; Procedure: neoadjuvant therapy |
| Part 2: lapatinib-trastuzumab combination | Experimental | Lapatinib 1000mg/day p.o. continuously for 28 days, in combination with trastuzumab 6mg/kg iv given on days 1 \& 8 pre-surgery \& one dose of 2mg/kg iv between days 15-19 post surgery. Both drugs should start 11 days (+2 or -1 day) before the scheduled surgery. Receives: Biological: trastuzumab; Drug: lapatinib ditosylate; Other: laboratory biomarker analysis; Procedure: adjuvant therapy; Procedure: neoadjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in apoptosis, by change in the tumor (morphological apoptosis and activated caspase 3) measured at diagnosis and at surgery (biological phase)
Measured: 10-13 days
Fall in proliferation between diagnosis and surgery by change in proliferation measured by Ki67 immunohistochemical assessment (%) at diagnosis and at surgery (biological phase)
Measured: 10-13 days
Relapse-free survival (clinical phase)
Measured: TBC
Secondary outcomes (5)
Changes in the angiogenic serum markers VEGF-A, VEGF R1, and CD105, measured at diagnosis, surgery (plus also tumor CD31) and 28-30 days post surgery (biological phase)
Measured: TBC
Pre-treatment and/or surgical expression of molecular markers (EGFR, Her-3, IGF1R, c-myc, AKT, p-ERK, pS6 inase, activated src, or truncated p95HER-2 expression)
Measured: TBC
Time to local recurrence (clinical phase)
Measured: TBC
Time to distant recurrence (clinical phase)
Measured: TBC
Overall survival (clinical phase)
Measured: TBC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startApr 2010
- Primary completion30 Aug 2017
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester, Manchester University NHS Foundation Trust, Cancer Research UK, Novartis
- Responsible party
- Sponsor
- Investigators
- Nigel Bundred, Principal investigator, Wythenshawe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104571
- Sponsor's protocol ID
- CDR0000669882
- Other IDs
- ICR-CTSU-2008-10017, UM-EPHOS-B, CRUK-08-002, MREC-09-H1208-52, ISRCTN-15004993, 2008-005466-30, EU-21029, 2008
- Acronym
- EPHOS-B
- Status last verified
- Feb 2018
- First submitted
- 13 Apr 2010
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bundred N, Cameron D, Armstrong A, Brunt AM, Cramer A, Dodwell D, Evans A, Hanby A, Hartup S, Hong A., Horgan K, Khattak I, Morden J, Naik J, Narayanan S, Ooi J, Shaaban A, Smith R, Webster-Smith M, Bliss J; on behalf of the EPHOS-B investigators. Effects of perioperative lapatinib and trastuzumab alone in combination in early HER2+ breast cancer - results from the EPHOS-B trial (CRUK/08/002). Eur J Cancer Supplements. 2016; 57 (Suppl 2): S5 #6LBA.
Bliss JM, Robison LE, Webster-Smith MF, Emson MA, Kilburn LS, Smith IE, Robertson J, Dowsett M, Bundred NJ, Cameron DA, Vidya R, Horgan K, Evans AA, Kokan JS, Pinhel I, A'Hern R; on behalf of the POETIC and EPHOS-B Trialists. A trial model for the future in the search for personalised medicine - the UK POETIC and EPHOS-B perioperative trials experience. Cancer Res. 2011; 71(24 Suppl): Abstract number OT2-03-04.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative AntiHER-2 Therapy on Early Breast Cancer Study - Biological Phase (EPHOS-B)
- ClinicalTrials.gov ID
- NCT01104571
- Acronym / sponsor ID
- EPHOS-B / CDR0000669882
- Conditions
- Breast Cancer
- Keywords
- HER2-positive breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, estrogen receptor-negative breast cancer, estrogen receptor-positive breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- University of Manchester, Manchester University NHS Foundation Trust, Cancer Research UK, Novartis
- Study start
- Apr 2010
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether trastuzumab or lapatinib ditosylate is more effective in treating women with early breast cancer.
Update June 2013:
Since the initial development of EPHOS-B in 2007 more evidence in relation to safety and efficacy of anti-HER2 therapies are now available, and in particular, a growing body of evidence that combinations of two anti-HER2 therapies are more effective than monotherapies. Therefore this study has been amended (PART 2) to a 1:1:2 ratio to control, perioperative trastuzumab or the combination of lapatinib and trastuzumab.
PURPOSE: This randomized phase III trial is studying trastuzumab to see how well it works compared with lapatinib ditosylate (and in since June 2013 - compared with a combination of lapatinib and trastuzumab) in treating women with early breast cancer.
Detailed description
OBJECTIVES:
Primary
- To determine whether pre-operative treatment of HER-2 positive breast cancer patients with anti-HER2 therapy consisting of trastuzumab (Herceptin®) vs lapatinib ditosylate inhibits proliferation or increases apoptosis.
- To compare the effects of trastuzumab (Herceptin®), lapatinib ditosylate and the combination of lapatinib ditosylate and trastuzumab (Herceptin®) on the inhibition of proliferation or increase of apoptosis
Secondary
- To determine whether pre-operative anti-HER2 treatment reduces serum angiogenic factors.
- To identify molecular predictors of biological response to anti-HER2 therapy
OUTLINE:
This is a multicenter study.Patients are stratified according to center. Patients are randomized to 1 of 3 treatment arms.
PART 1: From Protocol versions 1 to 4:
- Arm I (control): Patients receive no neoadjuvant or adjuvant therapy. Approximately 14 days after randomization, patients undergo either breast-conservation surgery or mastectomy.
- Arm II (trastuzumab [Herceptin®]): Patients receive neoadjuvant trastuzumab IV over 90 minutes on days 1 and 8. Approximately 11 days after beginning of neoadjuvant therapy, patients undergo either breast-conservation surgery or mastectomy, and receive adjuvant trastuzumab on day 15.
- Arm III (lapatinib ditosylate): Patients receive neoadjuvant oral lapatinib ditosylate once daily on days 1-11. Within 24 hours after completion of neoadjuvant therapy, patients undergo either breast-conservation surgery or mastectomy, and receive adjuvant lapatinib ditosylate once daily on days 12-28.
Patients also receive standard adjuvant systemic therapy, including endocrine therapy (for hormone-sensitive disease) and/or chemotherapy and radiotherapy.
PART 2: From Protocol Version 5 (June 2013)
- Arm I (control): Patients receive no neoadjuvant or adjuvant therapy. Approximately 14 days after randomization, patients undergo either breast-conservation surgery or mastectomy.
- Arm II (trastuzumab [Herceptin®]): Patients receive neoadjuvant trastuzumab IV over 90 minutes on days 1 and 8. Approximately 11 days after beginning of neoadjuvant therapy, patients undergo either breast-conservation surgery or mastectomy, and receive adjuvant trastuzumab on day 15.
- Arm III (lapatinib ditosylate and (trastuzumab [Herceptin®] combination): Patients receive oral lapatinib ditosylate once daily on days 1-11. Within 24 hours after completion of neoadjuvant therapy, patients undergo either breast-conservation surgery or mastectomy, and receive adjuvant lapatinib ditosylate once daily on days 12-28. Patients also receive neoadjuvant trastuzumab IV over 90 minutes on days 1 and 8 and receive adjuvant trastuzumab on day 15.
PART 1 and 2:
Patients also receive standard adjuvant systemic therapy, including endocrine therapy (for hormone-sensitive disease) and/or chemotherapy and radiotherapy.
All patients undergo blood and tissue sample collection periodically for biomarker research studies comprising biomarkers of proliferation, apoptosis, and angiogenesis.
After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 10 years.
Peer Reviewed and Funded by Cancer Research UK
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: Control | Other | Other: laboratory biomarker analysis, Procedure: therapeutic conventional surgeryNo peri-operative therapy given |
| Part 1: Trastuzumab | Experimental | Biological: trastuzumab, Other: laboratory biomarker analysis, Procedure: adjuvant therapy, Procedure: neoadjuvant therapyTrastuzumab 6mg/kg iv given on days 1 \& 8 pre-surgery \& one dose of 2mg/kg iv between days 15-19 post surgery. |
| Part 1: lapatinib | Experimental | Drug: lapatinib ditosylate, Other: laboratory biomarker analysis, Procedure: adjuvant therapy, Procedure: neoadjuvant therapyLapatinib 1500mg/day p.o. continuously for 28 days. Should start 11 days (+2 or -1 day) before the scheduled surgery |
| Part 2: Control | Other | Other: laboratory biomarker analysis, Procedure: therapeutic conventional surgeryNo peri-operative therapy |
| Part 2: Trastuzumab | Experimental | Biological: trastuzumab, Other: laboratory biomarker analysis, Procedure: adjuvant therapy, Procedure: neoadjuvant therapyTrastuzumab 6mg/kg iv given on days 1 \& 8 pre-surgery \& one dose of 2mg/kg iv between days 15-19 post surgery. |
| Part 2: lapatinib-trastuzumab combination | Experimental | Biological: trastuzumab, Drug: lapatinib ditosylate, Other: laboratory biomarker analysis, Procedure: adjuvant therapy, Procedure: neoadjuvant therapyLapatinib 1000mg/day p.o. continuously for 28 days, in combination with trastuzumab 6mg/kg iv given on days 1 \& 8 pre-surgery \& one dose of 2mg/kg iv between days 15-19 post surgery. Both drugs should start 11 days (+2 or -1 day) before the scheduled surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trastuzumabTrastuzumab 6mg/kg iv given on days 1 \& 8 pre-surgery \& one dose of 2mg/kg iv between days 15-19 post surgery | Biological | Part 1: Trastuzumab, Part 2: Trastuzumab, Part 2: lapatinib-trastuzumab combination |
| lapatinib ditosylatePart 1: Lapatinib 1500mg/day p.o. continuously for 28 days. Should start 11 days (+2 or -1 day) before the scheduled surgery. Part 2: Lapatinib 1000mg/day p.o. continuously for 28 days. Should start 11 days (+2 or -1 day) before the scheduled surgery. | Drug | Part 1: lapatinib, Part 2: lapatinib-trastuzumab combination |
| laboratory biomarker analysis | Other | Part 1: Control, Part 1: Trastuzumab, Part 1: lapatinib, Part 2: Control, Part 2: Trastuzumab, Part 2: lapatinib-trastuzumab combination |
| adjuvant therapy | Procedure or surgery | Part 1: Trastuzumab, Part 1: lapatinib, Part 2: Trastuzumab, Part 2: lapatinib-trastuzumab combination |
| neoadjuvant therapy | Procedure or surgery | Part 1: Trastuzumab, Part 1: lapatinib, Part 2: Trastuzumab, Part 2: lapatinib-trastuzumab combination |
| therapeutic conventional surgerytherapeutic conventional surgery | Procedure or surgery | Part 1: Control, Part 2: Control |
Primary outcome
Increase in apoptosis, by change in the tumor (morphological apoptosis and activated caspase 3) measured at diagnosis and at surgery (biological phase)
Time frame: 10-13 days
Fall in proliferation between diagnosis and surgery by change in proliferation measured by Ki67 immunohistochemical assessment (%) at diagnosis and at surgery (biological phase)
Time frame: 10-13 days
Relapse-free survival (clinical phase)
Time frame: TBC
5 secondary outcomes
Changes in the angiogenic serum markers VEGF-A, VEGF R1, and CD105, measured at diagnosis, surgery (plus also tumor CD31) and 28-30 days post surgery (biological phase)
Time frame: TBC
Pre-treatment and/or surgical expression of molecular markers (EGFR, Her-3, IGF1R, c-myc, AKT, p-ERK, pS6 inase, activated src, or truncated p95HER-2 expression)
Time frame: TBC
Time to local recurrence (clinical phase)
Time frame: TBC
Time to distant recurrence (clinical phase)
Time frame: TBC
Overall survival (clinical phase)
Time frame: TBC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- BackgroundBundred N, Cameron D, Armstrong A, Brunt AM, Cramer A, Dodwell D, Evans A, Hanby A, Hartup S, Hong A., Horgan K, Khattak I, Morden J, Naik J, Narayanan S, Ooi J, Shaaban A, Smith R, Webster-Smith M, Bliss J; on behalf of the EPHOS-B investigators. Effects of perioperative lapatinib and trastuzumab alone in combination in early HER2+ breast cancer - results from the EPHOS-B trial (CRUK/08/002). Eur J Cancer Supplements. 2016; 57 (Suppl 2): S5 #6LBA.
- BackgroundBliss JM, Robison LE, Webster-Smith MF, Emson MA, Kilburn LS, Smith IE, Robertson J, Dowsett M, Bundred NJ, Cameron DA, Vidya R, Horgan K, Evans AA, Kokan JS, Pinhel I, A'Hern R; on behalf of the POETIC and EPHOS-B Trialists. A trial model for the future in the search for personalised medicine - the UK POETIC and EPHOS-B perioperative trials experience. Cancer Res. 2011; 71(24 Suppl): Abstract number OT2-03-04.
- Cancer Research UK - lay summary of EPHOS-BLink provided by the sponsor.
- ISRCTN RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nigel Bundred principal investigator
Wythenshawe Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing trastuzumab, lapatinib ditosylate and laboratory biomarker analysis in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Results are not available in the source record.
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?
Increase in apoptosis, by change in the tumor (morphological apoptosis and activated caspase 3) measured at diagnosis and at surgery (biological phase) (time frame: 10-13 days). The study lists 3 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 NCT01104571, 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 17 Sep 2018.