Who is sponsoring NCT01891357?

NCT01891357 is sponsored by West German Study Group.

What condition does NCT01891357 study?

NCT01891357 studies Carcinoma, Ductal, Breast.

Is NCT01891357 still recruiting?

NCT01891357 is currently terminated. Last updated 17 September 2019.

Are results published for NCT01891357?

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

Last reviewed 2019-09-17 · How we verify

NCT01891357

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

Phase II Trial to Validate Markers for a Response Evaluation of a Combined Therapy in Patients With HER2+ Breast Cancer

Terminated Phase 2 Results posted Last updated 17 September 2019

What this trial tests

Phase 2 trial testing Biopsy before and after three weeks of study treatment in Carcinoma, Ductal, Breast in 64 participants. Terminated before completion.

Timeline

30 September 2013

Primary endpoint
16 November 2016

16 November 2016

Quick facts

Lead sponsor	West German Study Group
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	64
Start date	30 September 2013
Primary completion	16 November 2016
Estimated completion	16 November 2016
Sites	10 locations across Germany

Drugs / interventions tested

Biopsy before and after three weeks of study treatment
paclitaxel — full drug profile →
lapatinib (LAPATINIB) — full drug profile →
trastuzumab (trastuzumab) — full drug profile →

Conditions studied

Carcinoma, Ductal, Breast — all drugs for Carcinoma, Ductal, Breast →

Sponsor

West German Study Group — full company profile →

Who can join

Adults 18 to 75, female only, with Carcinoma, Ductal, Breast. 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.

Pathological Complete Response (pCR) Primary · Average of 16 weeks

pCR was defined at the time of surgery and measured by size of residual tumor, proportion of vital cells within invasive carcinoma, number of positive lymph nodes (ypN) and size of the largest lymph node metastasis and ductal carcinoma in situ (ypT). pCR is defined as ypT0/is, ypN0. Further exploratory pCR definitions were ypT0, ypN0 (total pCR) and ypT0/is (near pCR).

ypT0, ypN0

Group	Value	95% CI
Paclitaxel + Lapatinib + Trastuzumab	19

ypT0/is

Group	Value	95% CI
Paclitaxel + Lapatinib + Trastuzumab	27

ypT0/is, ypN0

Group	Value	95% CI
Paclitaxel + Lapatinib + Trastuzumab	25

Adverse events — posted to ClinicalTrials.gov

Time frame: AE collection from signature of ICF until end of study per patient, up to 3 years.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Paclitaxel + Lapatinib + Trastuzumab

Serious: 16/61 (26%)

Deaths: —

Serious adverse events (19 terms)

Reaction	System	Paclitaxel + Lapatinib + T…
diarrhoea	Gastrointestinal disorders	—
Death	Psychiatric disorders	—
anxiety	Psychiatric disorders	—
Cholecystitis	Gastrointestinal disorders	—
Decreased appetite	Gastrointestinal disorders	—
Dehydration	Renal and urinary disorders	—
Device related thrombosis	Vascular disorders	—
Fatigue	General disorders	—
hypokaleamia	Metabolism and nutrition disorders	—
impaired healing	Skin and subcutaneous tissue disorders	—
Leukopenia	Blood and lymphatic system disorders	—
Mucosal Inflammation	Skin and subcutaneous tissue disorders	—
Ophthalmic herpes simplex	Eye disorders	—
Pneumonia	Infections and infestations	—
septic shock	Infections and infestations	—
Subcutaneous abscess	Skin and subcutaneous tissue disorders	—
Syncope	Cardiac disorders	—
Urinary tract infection	Renal and urinary disorders	—
Urosepsis	Renal and urinary disorders	—

Other adverse events (20 terms — click to expand)

Reaction	System	Paclitaxel + Lapatinib + T…
Gastrointestinal disorders	Gastrointestinal disorders	—
Nervous system disorders	Nervous system disorders	—
Skin and subcutaneous tissue disorders	Skin and subcutaneous tissue disorders	—
General disorders and administration site conditions	General disorders	—
Respiratory, thoracic and mediastinal disorders	Respiratory, thoracic and mediastinal disorders	—
Infections and infestations	Infections and infestations	—
Investigations	Investigations	—
Blood and lymphatic system disorders	Blood and lymphatic system disorders	—
Psychiatric disorders	Psychiatric disorders	—
Vascular disorders	Vascular disorders	—
Musculoskeletal and connective tissue disorders	Musculoskeletal and connective tissue disorders	—
Metabolism and nMetabolism and nutrition disordersutrition disorders	Metabolism and nutrition disorders	—
Eye disorders	Eye disorders	—
Immune system disorders	Immune system disorders	—
Injury, poisoning and procedural complications	Injury, poisoning and procedural complications	—
Ear and labyrinth disorders	Ear and labyrinth disorders	—
Hepatobiliary disorders	Hepatobiliary disorders	—
Renal and urinary disorders	Renal and urinary disorders	—
Cardiac disorders	Cardiac disorders	—
Reproductive system and breast disorders	Reproductive system and breast disorders	—

Most-reported serious reactions: diarrhoea, Death, anxiety, Cholecystitis, Decreased appetite, Dehydration, Device related thrombosis, Fatigue.

Data from ClinicalTrials.gov NCT01891357 adverse events section.

Sponsor's own description

The Neo-PREDICT-HER2 Study is phase II trial to validate predictive markers for the response evaluation of a combined chemo-immunotherapy in patients with HER2-positive early breast cancer. The only treatment arm consists of Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Carcinoma, Ductal, Breast

Currently open trials in the same condition.

NCT07214532 — Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer · NA · recruiting

Other West German Study Group trials

Trials by the same sponsor.

NCT07242352 — Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinica · Phase 3 · not yet recruiting
NCT07178730 — NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple- · Phase 3 · not yet recruiting
NCT03988036 — A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast C · Phase 2 · completed
NCT04055493 — Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC · Phase 3 · active not recruiting
NCT02269813 — PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative B · completed

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 NCT01891357 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by West German Study Group
Last refreshed: 17 September 2019

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/NCT01891357.

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