NCT00545688 is a Phase 2 clinical trial of Herceptin in Breast Cancer, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT00545688?

NCT00545688 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT00545688?

Interventions in NCT00545688: Herceptin, Docetaxel, Pertuzumab.

What condition does NCT00545688 study?

NCT00545688 studies Breast Cancer.

Is NCT00545688 still recruiting?

NCT00545688 is currently completed. Last updated 15 August 2017.

Are results published for NCT00545688?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-08-15 · How we verify

NCT00545688

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.

Completed Phase 2 Results posted Last updated 15 August 2017

What this trial tests

Phase 2 trial testing Herceptin in Breast Cancer in 417 participants. Completed in 22 September 2014.

Timeline

26 June 2006

Primary endpoint
22 September 2014

22 September 2014

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	417
Start date	26 June 2006
Primary completion	22 September 2014
Estimated completion	22 September 2014
Sites	77 locations across Italy, Russia, Peru, Austria, Sweden, Taiwan, United Kingdom, Israel

Drugs / interventions tested

Herceptin (trastuzumab) — full drug profile →
Docetaxel (Docetaxel) — full drug profile →
Pertuzumab (pertuzumab) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Achieving Pathological Complete Response (pCR) Primary · Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)

pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants with invalid/missing pCR assessments were defined as non-responders

Group	Value	95% CI
Trastuzumab+Docetaxel	29.0	20.6 – 38.5
Trastuzumab+Pertuzumab+Docetaxel	45.8	36.1 – 55.7
Trastuzumab+Pertuzumab	16.8	10.3 – 25.3
Pertuzumab+Docetaxel	24.0	15.8 – 33.7

Percentage of Participants Achieving Best Primary Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Disease Progression [PD]) During Neo-Adjuvant Treatment by X-Ray/Mammography Secondary · Baseline up to Cycle 4 (assessed at, Baseline and Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months

Tumor assessments were made based upon the Response Evaluation Criteria in Solid Tumors (RECIST) criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for primary breast tumor using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is greater than (\>)0 at screening or cycle 1 Day 1; PR: if measurement is at least a 30 percent (%) decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient

Group	Value	95% CI
Trastuzumab+Docetaxel	18.3
Trastuzumab+Pertuzumab+Docetaxel	19.0
Trastuzumab+Pertuzumab	13.1
Pertuzumab+Docetaxel	19.1

Group	Value	95% CI
Trastuzumab+Docetaxel	49.3
Trastuzumab+Pertuzumab+Docetaxel	46.6
Trastuzumab+Pertuzumab	36.1
Pertuzumab+Docetaxel	46.8

Group	Value	95% CI
Trastuzumab+Docetaxel	31.0
Trastuzumab+Pertuzumab+Docetaxel	32.8
Trastuzumab+Pertuzumab	44.3
Pertuzumab+Docetaxel	34.0

Group	Value	95% CI
Trastuzumab+Docetaxel	1.4
Trastuzumab+Pertuzumab+Docetaxel	1.7
Trastuzumab+Pertuzumab	6.6
Pertuzumab+Docetaxel	0.0

Percentage of Participants Achieving pCR by Breast Cancer Type Primary · Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)

pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Based on the type of breast cancer participants were categorized as those with 1. Operable breast cancer, 2. Inflammatory breast cancer and 3. Locally advanced breast cancer. Participants with invalid/missing pCR assessments were defined as non-responders.

Operable Breast Cancer (n=64,65,65,60)

Group	Value	95% CI
Trastuzumab+Docetaxel	23.4	13.8 – 35.7
Trastuzumab+Pertuzumab+Docetaxel	47.7	35.1 – 60.5
Trastuzumab+Pertuzumab	16.9	8.8 – 28.3
Pertuzumab+Docetaxel	26.7	16.1 – 39.7

Inflammatory Breast Cancer (n=7,10,7,5)

Group	Value	95% CI
Trastuzumab+Docetaxel	14.3	0.4 – 57.9
Trastuzumab+Pertuzumab+Docetaxel	40.0	12.2 – 73.8
Trastuzumab+Pertuzumab	28.6	3.7 – 71.0
Pertuzumab+Docetaxel	40.0	5.3 – 85.3

Locally Advance Breast Cancer (36,32,35,31)

Group	Value	95% CI
Trastuzumab+Docetaxel	41.7	25.5 – 59.2
Trastuzumab+Pertuzumab+Docetaxel	43.8	26.4 – 62.3
Trastuzumab+Pertuzumab	14.3	4.8 – 30.3
Pertuzumab+Docetaxel	16.1	5.5 – 33.7

Percentage of Participants Achieving pCR by Hormone Receptor Status Primary · Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)

pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants were classified as Estrogen and/or Progesterone positive (+ve), Estrogen and/or Progesterone negative (-ve) or receptor status unknown. Participants with invalid/missing pCR assessments were defined as non-responders.

Estrogen and/or Progesterone +ve (n=50,50,51,46)

Group	Value	95% CI
Trastuzumab+Docetaxel	20.0	10.0 – 33.7
Trastuzumab+Pertuzumab+Docetaxel	26.0	14.6 – 40.3
Trastuzumab+Pertuzumab	5.9	1.2 – 16.2
Pertuzumab+Docetaxel	17.4	7.8 – 31.4

Estrogen and/or Progesterone -ve (n=57,57,55,50)

Group	Value	95% CI
Trastuzumab+Docetaxel	36.8	24.4 – 50.7
Trastuzumab+Pertuzumab+Docetaxel	63.2	49.3 – 75.6
Trastuzumab+Pertuzumab	27.3	16.1 – 41.0
Pertuzumab+Docetaxel	30.0	17.9 – 44.6

Receptor Status Unknown (0,0,1,0)

Group	Value	95% CI
Trastuzumab+Docetaxel	NA	NA – NA
Trastuzumab+Pertuzumab+Docetaxel	NA	NA – NA
Trastuzumab+Pertuzumab	0.0	0.0 – 97.5
Pertuzumab+Docetaxel	NA	NA – NA

Percentage of Participants Achieving pCR by Lymph Node Status Primary · Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)

pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Lymph node status was defined as either negative lymph node at surgery or positive lymph node at surgery. Participants with invalid/missing pCR assessments were defined as non-responders.

pCR achieved and Negative Lymph Nodes at Surgery

Group	Value	95% CI
Trastuzumab+Docetaxel	21.5
Trastuzumab+Pertuzumab+Docetaxel	39.3
Trastuzumab+Pertuzumab	11.2
Pertuzumab+Docetaxel	17.7

pCR achieved and Positive Lymph Nodes at Surgery

Group	Value	95% CI
Trastuzumab+Docetaxel	7.5
Trastuzumab+Pertuzumab+Docetaxel	6.5
Trastuzumab+Pertuzumab	5.6
Pertuzumab+Docetaxel	6.3

Percentage of Participants Achieving pCR by Presence or Absence of Residual Intraductal Carcinoma (DCIS) / Intalobular Carcinoma (LCIS) Primary · Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)

pCR Achieved and No residual DCIS/LCIS at Surgery

Group	Value	95% CI
Trastuzumab+Docetaxel	16.8
Trastuzumab+Pertuzumab+Docetaxel	36.4
Trastuzumab+Pertuzumab	9.3
Pertuzumab+Docetaxel	17.7

pCR Achieved and Residual DCIS/LCIS at Surgery

Group	Value	95% CI
Trastuzumab+Docetaxel	12.1
Trastuzumab+Pertuzumab+Docetaxel	9.3
Trastuzumab+Pertuzumab	7.5
Pertuzumab+Docetaxel	6.3

Percentage of Participants Achieving Best Overall Response (CR, PR, SD or PD) During Neo-Adjuvant Period by X-Ray/Mammography Secondary · Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months

Tumor assessments were made based on the RECIST criteria - version 1.0 The overall response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is \>0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased com

Group	Value	95% CI
Trastuzumab+Docetaxel	18.3
Trastuzumab+Pertuzumab+Docetaxel	18.9
Trastuzumab+Pertuzumab	12.7
Pertuzumab+Docetaxel	18.6

Group	Value	95% CI
Trastuzumab+Docetaxel	49.3
Trastuzumab+Pertuzumab+Docetaxel	49.1
Trastuzumab+Pertuzumab	34.5
Pertuzumab+Docetaxel	46.5

Group	Value	95% CI
Trastuzumab+Docetaxel	31.0
Trastuzumab+Pertuzumab+Docetaxel	30.2
Trastuzumab+Pertuzumab	45.5
Pertuzumab+Docetaxel	34.9

Group	Value	95% CI
Trastuzumab+Docetaxel	1.4
Trastuzumab+Pertuzumab+Docetaxel	1.9
Trastuzumab+Pertuzumab	7.3
Pertuzumab+Docetaxel	0.0

Percentage of Participants Achieving Best Primary Breast Tumor Response (CR, PR, SD or PD) During Neo-Adjuvant Period by Clinical Examination Secondary · Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months

Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for primary breast tumor using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is \>0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for

Group	Value	95% CI
Trastuzumab+Docetaxel	23.2
Trastuzumab+Pertuzumab+Docetaxel	30.7
Trastuzumab+Pertuzumab	16.7
Pertuzumab+Docetaxel	20.9

Group	Value	95% CI
Trastuzumab+Docetaxel	56.6
Trastuzumab+Pertuzumab+Docetaxel	57.4
Trastuzumab+Pertuzumab	51.0
Pertuzumab+Docetaxel	50.5

Group	Value	95% CI
Trastuzumab+Docetaxel	20.2
Trastuzumab+Pertuzumab+Docetaxel	11.9
Trastuzumab+Pertuzumab	30.4
Pertuzumab+Docetaxel	28.6

Group	Value	95% CI
Trastuzumab+Docetaxel	0.0
Trastuzumab+Pertuzumab+Docetaxel	0.0
Trastuzumab+Pertuzumab	2.0
Pertuzumab+Docetaxel	0.0

Percentage of Participants Achieving Best Overall Response (CR, PR, SD or PD) During the Neo-Adjuvant Period by Clinical Examination Secondary · Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months

Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is \>0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased co

Group	Value	95% CI
Trastuzumab+Docetaxel	21.6
Trastuzumab+Pertuzumab+Docetaxel	25.0
Trastuzumab+Pertuzumab	11.2
Pertuzumab+Docetaxel	15.9

Group	Value	95% CI
Trastuzumab+Docetaxel	59.8
Trastuzumab+Pertuzumab+Docetaxel	63.0
Trastuzumab+Pertuzumab	55.1
Pertuzumab+Docetaxel	58.0

Group	Value	95% CI
Trastuzumab+Docetaxel	17.5
Trastuzumab+Pertuzumab+Docetaxel	12.0
Trastuzumab+Pertuzumab	31.6
Pertuzumab+Docetaxel	26.1

Group	Value	95% CI
Trastuzumab+Docetaxel	1.0
Trastuzumab+Pertuzumab+Docetaxel	0.0
Trastuzumab+Pertuzumab	2.0
Pertuzumab+Docetaxel	0.0

Percentage of Participants Achieving Clinical Response During Neo-Adjuvant Period by X-Ray/Mammography Secondary · Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months

Clinical response was determined based on tumor measurements by sponsor in combination with tumor response assessment by investigator. Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of '0' is noted at a given

Primary Breast Tumor (n=71,58,61,47)

Group	Value	95% CI
Trastuzumab+Docetaxel	67.6	55.5 – 78.2
Trastuzumab+Pertuzumab+Docetaxel	65.5	51.9 – 77.5
Trastuzumab+Pertuzumab	49.2	36.1 – 62.3
Pertuzumab+Docetaxel	66.0	50.7 – 79.1

Overall Response (n=71,53,55,43)

Group	Value	95% CI
Trastuzumab+Docetaxel	67.6	55.5 – 78.2
Trastuzumab+Pertuzumab+Docetaxel	67.9	53.7 – 80.1
Trastuzumab+Pertuzumab	47.3	33.7 – 61.2
Pertuzumab+Docetaxel	65.1	49.1 – 79.0

Percentage of Participants Achieving Clinical Response During Neo-Adjuvant Period by Clinical Examination Secondary · Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months

Primary Breast Tumor (n=99,101,102,91)

Group	Value	95% CI
Trastuzumab+Docetaxel	79.8	70.5 – 87.2
Trastuzumab+Pertuzumab+Docetaxel	88.1	80.2 – 93.7
Trastuzumab+Pertuzumab	67.6	57.7 – 76.6
Pertuzumab+Docetaxel	71.4	61.0 – 80.4

Overall Response (n=97,100,98,88)

Group	Value	95% CI
Trastuzumab+Docetaxel	81.4	72.3 – 88.6
Trastuzumab+Pertuzumab+Docetaxel	88.0	80.0 – 93.6
Trastuzumab+Pertuzumab	66.3	56.1 – 75.6
Pertuzumab+Docetaxel	73.9	63.4 – 82.7

Time to Clinical Response During Neo-Adjuvant Treatment Period Secondary · Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months

Time to clinical response was defined as the time from the date of first dose received to the date of assessment of clinical response. Time to Clinical response was determined by Kaplan-Meier estimates. Tumor assessments were made based on the RECIST criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using th

Group	Value	95% CI
Trastuzumab+Docetaxel	6.3	6.0 – 7.0
Trastuzumab+Pertuzumab+Docetaxel	6.3	4.0 – 7.0
Trastuzumab+Pertuzumab	6.9	6.0 – 9.0
Pertuzumab+Docetaxel	7.3	6.0 – 9.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were recorded from the date of Screening until the clinical cut off date 20th October 2014 up to 7 years.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Trastuzumab+Docetaxel

Serious: 21/107 (20%)

Deaths: —

Trastuzumab+Pertuzumab+Docetaxel

Serious: 22/107 (21%)

Deaths: —

Trastuzumab+Pertuzumab

Serious: 19/108 (18%)

Deaths: —

Pertuzumab+Docetaxel

Serious: 21/94 (22%)

Deaths: —

Serious adverse events (43 terms)

Reaction	System	Trastuzumab+Docetaxel	Trastuzumab+Pertuzumab+Doc…	Trastuzumab+Pertuzumab	Pertuzumab+Docetaxel
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—
Left ventricular dysfunction	Cardiac disorders	—	—	—	—
Pyelonephritis acute	Infections and infestations	—	—	—	—
Wound infection	Infections and infestations	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Neutropenic infection	Infections and infestations	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Breast abscess	Infections and infestations	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—
H1N1 influenza	Infections and infestations	—	—	—	—
Infection	Infections and infestations	—	—	—	—
Neutropenic sepsis	Infections and infestations	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—
Septic shock	Infections and infestations	—	—	—	—
Staphylococcal sepsis	Infections and infestations	—	—	—	—
Imparied healing	General disorders	—	—	—	—
Abdominal strangulated hernia	Gastrointestinal disorders	—	—	—	—
Duodenal ulcer haemorrhage	Gastrointestinal disorders	—	—	—	—
Angina pectoris	Cardiac disorders	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—

Other adverse events (72 terms — click to expand)

Reaction	System	Trastuzumab+Docetaxel	Trastuzumab+Pertuzumab+Doc…	Trastuzumab+Pertuzumab	Pertuzumab+Docetaxel
Neutropenia	Blood and lymphatic system disorders	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Mucosal inflammation	General disorders	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Asthenia	General disorders	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—
General Disorder	General disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—
Radiation skin injury	Injury, poisoning and procedural complications	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—
Nail disorder	Skin and subcutaneous tissue disorders	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Bone pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Hot flush	Vascular disorders	—	—	—	—
Lymphoedema	Vascular disorders	—	—	—	—
Drug hypersensitivity	Immune system disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—

Most-reported serious reactions: Febrile neutropenia, Neutropenia, Left ventricular dysfunction, Pyelonephritis acute, Wound infection, Pyrexia, Diarrhoea, Neutropenic infection.

Data from ClinicalTrials.gov NCT00545688 adverse events section.

Sponsor's own description

This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial.
Gianni L, Pienkowski T, Im YH, Roman L, et al · · 2012 · cited 1624× · PMID 22153890 · DOI 10.1016/s1470-2045(11)70336-9
5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial.
Gianni L, Pienkowski T, Im YH, Tseng LM, et al · · 2016 · cited 622× · PMID 27179402 · DOI 10.1016/s1470-2045(16)00163-7
Efficacy, Safety, and Tolerability of Pertuzumab, Trastuzumab, and Docetaxel for Patients With Early or Locally Advanced ERBB2-Positive Breast Cancer in Asia: The PEONY Phase 3 Randomized Clinical Trial.
Shao Z, Pang D, Yang H, Li W, et al · · 2020 · cited 149× · PMID 31647503 · DOI 10.1001/jamaoncol.2019.3692
Current approaches and future directions in the treatment of HER2-positive breast cancer.
Hurvitz SA, Hu Y, O'Brien N, Finn RS. · · 2013 · cited 104× · PMID 22658319 · DOI 10.1016/j.ctrv.2012.04.008
Interaction of host immunity with HER2-targeted treatment and tumor heterogeneity in HER2-positive breast cancer.
Griguolo G, Pascual T, Dieci MV, Guarneri V, et al · · 2019 · cited 91× · PMID 30922362 · DOI 10.1186/s40425-019-0548-6
Biomarker analysis of the NeoSphere study: pertuzumab, trastuzumab, and docetaxel versus trastuzumab plus docetaxel, pertuzumab plus trastuzumab, or pertuzumab plus docetaxel for the neoadjuvant treatment of HER2-positive breast cancer.
Bianchini G, Kiermaier A, Bianchi GV, Im YH, et al · · 2017 · cited 90× · PMID 28183321 · DOI 10.1186/s13058-017-0806-9
Intrinsic subtypes, PIK3CA mutation, and the degree of benefit from adjuvant trastuzumab in the NSABP B-31 trial.
Pogue-Geile KL, Song N, Jeong JH, Gavin PG, et al · · 2015 · cited 85× · PMID 25559813 · DOI 10.1200/jco.2014.56.2439
Development and clinical application of anti-HER2 monoclonal and bispecific antibodies for cancer treatment.
Yu S, Liu Q, Han X, Qin S, et al · · 2017 · cited 82× · PMID 29209558 · DOI 10.1186/s40164-017-0091-4

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Other Hoffmann-La Roche trials

Trials by the same sponsor.

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NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00545688 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 15 August 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00545688.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00545688

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (43 terms)

Sponsor's own description

Publications & conference data

Related trials

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Other recruiting trials for Breast Cancer

Other Hoffmann-La Roche trials

Verify against primary sources