NCT02896855 (PUFFIN) is a Phase 3 clinical trial of Docetaxel in Breast Cancer, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT02896855?

NCT02896855 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT02896855?

Interventions in NCT02896855: Docetaxel, Pertuzumab, Placebo, Trastuzumab.

What condition does NCT02896855 study?

NCT02896855 studies Breast Cancer.

Is NCT02896855 still recruiting?

NCT02896855 is currently completed. Last updated 16 December 2021.

Are results published for NCT02896855?

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

Last reviewed 2021-12-16 · How we verify

NCT02896855: PUFFIN

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

A Study to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel Versus Placebo + Trastuzumab + Docetaxel in Previously Untreated Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer

Completed Phase 3 Results posted Last updated 16 December 2021

What this trial tests

Phase 3 trial testing Docetaxel in Breast Cancer in 243 participants. Completed in 22 January 2021.

Timeline

13 September 2016

Primary endpoint
27 June 2018

22 January 2021

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	243
Start date	13 September 2016
Primary completion	27 June 2018
Estimated completion	22 January 2021
Sites	15 locations across China

Drugs / interventions tested

Docetaxel (Docetaxel) — full drug profile →
Pertuzumab (pertuzumab) — full drug profile →
Placebo
Trastuzumab (trastuzumab) — 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, any sex, 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.

Progression-Free Survival, as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Primary · From date of randomization until date of PFS event (Median [range] time on study for Arm A vs. Arm B at Primary analysis: 57.14 [3.3-93.3] weeks vs. 59.64 [0.9-90.4] weeks; Final analysis: 145.29 [3.3-225.3] weeks vs. 174.79 [0.9-226.1] weeks)

Progression-free survival (PFS) was defined as the time from randomization to first occurrence of progressive disease (PD), as determined by the investigator using RECIST v1.1, or death from any cause within 18 weeks after the last tumor assessment, whichever occurred first. As per RECIST v1.1, PD is defined as a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeters (mm), and the appearance of new lesions. The Kaplan-Meier approach was used to estimate median PFS for each treatment arm. Data for participants who did not

Primary Analysis

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	12.4	10.4 – 12.7
Arm B: Pertuzumab + Trastuzumab + Docetaxel	14.5	12.5 – 18.6

Final Analysis

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	12.5	10.4 – 14.6
Arm B: Pertuzumab + Trastuzumab + Docetaxel	16.5	12.7 – 20.2

Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Progression-Free Survival at 1 to 3 Years, as Determined by the Investigator Using RECIST v1.1 Primary · At 1, 2, and 3 years

Progression-free survival (PFS) was defined as the time from randomization to first occurrence of progressive disease (PD), as determined by the investigator using RECIST v1.1, or death from any cause within 18 weeks after the last tumor assessment, whichever occurred first. As per RECIST v1.1, PD is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm, and the appearance of new lesions. The Kaplan-Meier approach was used to estimate the percentage of participants who were event-free for PFS at 1, 2, and 3 years. Data for part

1 Year

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	52.90	43.75 – 62.04
Arm B: Pertuzumab + Trastuzumab + Docetaxel	66.37	57.86 – 74.87

2 Years

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	19.19	11.85 – 26.53
Arm B: Pertuzumab + Trastuzumab + Docetaxel	37.85	29.03 – 46.66

3 Years

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	12.73	6.48 – 18.97
Arm B: Pertuzumab + Trastuzumab + Docetaxel	29.44	21.04 – 37.84

Overall Survival Secondary · From date of randomization until the date of death from any cause (Median [range] time on study for Arm A vs. Arm B at Final analysis: 145.29 [3.3-225.3] weeks vs. 174.79 [0.9-226.1] weeks)

Overall survival (OS) was defined as the time from randomization to death from any cause. The Kaplan-Meier approach was used to estimate median OS for each treatment arm. Participants who were alive or lost to follow-up at the time of the analysis were censored at the date they were last known to be alive. Participants with no post-baseline information were censored at the time of randomization plus 1 day. The results reported here are from the final analysis. At the primary completion date, the median duration of OS had not been reached and OS data was not considered mature due to the few num

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	NA	22.1 – NA
Arm B: Pertuzumab + Trastuzumab + Docetaxel	NA	30.6 – NA

Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Overall Survival at 1 to 3 Years Secondary · At 1, 2, and 3 Years

Overall survival (OS) was defined as the time from randomization to death from any cause. The Kaplan-Meier approach was used to estimate the percentage of participants who were event-free for OS (i.e., alive) at 1, 2, and 3 years. Participants who were alive or lost to follow-up at the time of the analysis were censored at the date they were last known to be alive. Participants with no post-baseline information were censored at the time of randomization plus 1 day. At final analysis, the median \[range\] time on study for Arm A vs. Arm B was 145.29 \[3.3-225.3\] weeks vs. 174.79 \[0.9-226.1\]

1 Year

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	90.64	85.37 – 95.91
Arm B: Pertuzumab + Trastuzumab + Docetaxel	93.44	89.05 – 97.84

2 Years

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	73.85	65.80 – 81.91
Arm B: Pertuzumab + Trastuzumab + Docetaxel	78.87	71.50 – 86.24

3 Years

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	58.41	49.12 – 67.69
Arm B: Pertuzumab + Trastuzumab + Docetaxel	70.79	62.50 – 79.09

Percentage of Participants With Measurable Disease at Baseline Who Achieved an Objective Response (Complete or Partial Response), as Determined by the Investigator Using RECIST v1.1 Secondary · At Baseline and every 9 weeks from date of randomization until disease progression or death, whichever occurs first (Median [range] time on study for Arm A vs. Arm B at Primary analysis: 57.14 [3.3-93.3] weeks vs. 59.64 [0.9-90.4] weeks)

An objective response was defined as a complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1. As per RECIST v1.1, CR is defined as the disappearance of all target lesions, and PR is defined as at least a 30% decrease in the sum of diameters of target lesions. Also per RECIST v1.1, stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum on study; PD is defined as a 20% increase in the sum of the diameters of target lesions,

Objective Response (CR + PR)

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	69.1	58.88 – 78.07
Arm B: Pertuzumab + Trastuzumab + Docetaxel	79.0	70.01 – 86.38

Complete Response (CR)

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	8.2	3.63 – 15.61
Arm B: Pertuzumab + Trastuzumab + Docetaxel	5.7	2.13 – 12.02

Partial Response (PR)

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	60.8	50.39 – 70.58
Arm B: Pertuzumab + Trastuzumab + Docetaxel	73.3	63.81 – 81.49

Stable Disease (SD)

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	20.6	13.07 – 30.03
Arm B: Pertuzumab + Trastuzumab + Docetaxel	15.2	8.97 – 23.56

Progressive Disease (PD)

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	4.1	1.13 – 10.22
Arm B: Pertuzumab + Trastuzumab + Docetaxel	3.8	1.05 – 9.47

Missing or Unevaluable

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	6.2	NA – NA
Arm B: Pertuzumab + Trastuzumab + Docetaxel	1.9	NA – NA

Duration of Objective Response, as Determined by the Investigator Using RECIST v1.1 Secondary · From date of first occurrence of documented objective response to date of event (Median [range] time on study for Arm A vs. Arm B at Primary analysis: 57.14 [3.3-93.3] weeks vs. 59.64 [0.9-90.4] weeks)

Duration of objective response was defined as the time from the first occurrence of a documented objective response (complete response \[CR\] or partial response \[PR\]) to the time of disease progression, as determined by the investigator using RECIST v1.1, or death from any cause within 18 weeks after the last tumor assessment, whichever occurred first. As per RECIST v1.1, CR is defined as the disappearance of all target lesions, and PR is defined as at least a 30% decrease in the sum of diameters of target lesions. The Kaplan-Meier approach was used to estimate median duration of objective

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	10.4	8.3 – 15.4
Arm B: Pertuzumab + Trastuzumab + Docetaxel	12.4	10.6 – 14.9

Number of Participants With at Least One Adverse Event Secondary · From first dose of study drug until 42 days after last dose of study drug (up to 4 years, 4 months)

The number of participants per treatment arm experiencing at least one adverse event, including all non-serious and serious adverse events, is reported here. Adverse events reported prior to first crossover treatment were included in the Placebo arm, and in the Crossover arm after that date, for participants in Arm A who crossed over from placebo to pertuzumab. At final analysis, the median \[range\] time on study treatment with placebo or pertuzumab per arm was: Arm A - Placebo: 52.3 \[3-207\] weeks; Arm B - Pertuzumab: 66.1 \[3-225\] weeks; Arm A - Crossover to Pertuzumab: 18.1 \[12-24\] wee

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	115
Arm B: Pertuzumab + Trastuzumab + Docetaxel	121
Arm A: Crossover to Pertuzumab + Trastuzumab + Docetaxel	5

Number of Participants With at Least One Grade ≥3 Adverse Event Secondary · From first dose of study drug until 42 days after last dose of study drug (up to 4 years, 4 months)

Adverse event (AE) severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0); if the AE was not specifically listed, the following grades of severity were used: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening or disabling; and Grade 5 = death. Severe and serious are not synonymous. Severity refers to the intensity of an AE, whereas a serious AE must meet criteria set out in the protocol; both were independently assessed for each AE. AEs reported prior to first crossover treatmen

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	83
Arm B: Pertuzumab + Trastuzumab + Docetaxel	90
Arm A: Crossover to Pertuzumab + Trastuzumab + Docetaxel	1

Number of Participants With at Least One Adverse Event Leading to Withdrawal From Any Treatment Secondary · From first dose of study drug until 42 days after last dose of study drug (up to 4 years, 4 months)

Adverse events reported prior to first crossover treatment were included in the Placebo arm, and in the Crossover arm after that date, for participants in Arm A who crossed over from placebo to pertuzumab. At final analysis, the median \[range\] time on study treatment with placebo or pertuzumab per arm was: Arm A - Placebo: 52.3 \[3-207\] weeks; Arm B - Pertuzumab: 66.1 \[3-225\] weeks; Arm A - Crossover to Pertuzumab: 18.1 \[12-24\] weeks.

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	10
Arm B: Pertuzumab + Trastuzumab + Docetaxel	15
Arm A: Crossover to Pertuzumab + Trastuzumab + Docetaxel	0

Number of Participants With Symptomatic Left Ventricular Systolic Dysfunction (LVSD), as Determined Using Echocardiography (ECHO) or Multiple-Gated Acquisition (MUGA) Scan Secondary · From first dose of study drug until 42 days after last dose of study drug (up to 4 years, 4 months)

The number of participants with symptomatic left ventricular systolic dysfunction (LVSD) at any time during the study, as determined using echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan, were summarized by treatment arm. Symptomatic LVSD was evaluated according to NCI CTCAE v4.0 (for "heart failure") and the New York Heart Association (NYHA) classification. At final analysis, the median \[range\] time on study treatment with placebo or pertuzumab per arm was: Arm A - Placebo: 52.3 \[3-207\] weeks; Arm B - Pertuzumab: 66.1 \[3-225\] weeks; Arm A - Crossover to Pertuzumab: 18.

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	0
Arm B: Pertuzumab + Trastuzumab + Docetaxel	0
Arm A: Crossover to Pertuzumab + Trastuzumab + Docetaxel	0

Number of Participants With an Asymptomatic Decline in Left Ventricular Ejection Fraction (LVEF) Event, as Determined Using ECHO or MUGA Scan Secondary · From first dose of study drug until 42 days after last dose of study drug (up to 4 years, 4 months)

An asymptomatic decline in LVEF event is reported as an adverse event of "ejection fraction decreased" and is defined as either of the following: an absolute decrease in LVEF of ≥10 percentage points from baseline to an LVEF of \<50%; or an asymptomatic decrease in LVEF requiring treatment or leading to discontinuation of pertuzumab (or placebo) and trastuzumab. At final analysis, the median \[range\] time on study treatment with placebo or pertuzumab per arm was: Arm A - Placebo: 52.3 \[3-207\] weeks; Arm B - Pertuzumab: 66.1 \[3-225\] weeks; Arm A - Crossover to Pertuzumab: 18.1 \[12-24\] we

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	0
Arm B: Pertuzumab + Trastuzumab + Docetaxel	2
Arm A: Crossover to Pertuzumab + Trastuzumab + Docetaxel	0

Number of Participants by the LVEF Abnormality Status Categories Over Time, as Determined by the Change From Baseline in LVEF Using ECHO or MUGA Scans Secondary · Baseline, Weeks 9, 18, 27, 36, 45, 54, 63, 72, 81, 90, 99, 108, 117, 126, 135, 144, 153, 162, 171, 180, 189, 198, 207, 216, and 225, Study Drug Discontinuation Visit (up to 4 years, 4 months), and Treatment-Free Follow-Up at 6 months, and 1 and 2 years

Left ventricular ejection fraction (LVEF) is the measurement of how much blood is being pumped out of the left ventricle of the heart with each contraction. LVEF was calculated using the modified Simpson method and must have been ≥55% at baseline as determined by the local facility before a participant could be enrolled in the study. The investigator decided which method of LVEF assessment (ECHO \[preferred\] or MUGA scan) would be used for each participant at baseline, and the same method was to be used throughout the study, to the extent possible. The LVEF abnormality status categories, as a

Week 9

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	57
Arm B: Pertuzumab + Trastuzumab + Docetaxel	63
Arm A: Placebo + Trastuzumab + Docetaxel	51
Arm B: Pertuzumab + Trastuzumab + Docetaxel	52
Arm A: Placebo + Trastuzumab + Docetaxel	3
Arm B: Pertuzumab + Trastuzumab + Docetaxel	4
Arm A: Placebo + Trastuzumab + Docetaxel	0
Arm B: Pertuzumab + Trastuzumab + Docetaxel	0

Week 18

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	61
Arm B: Pertuzumab + Trastuzumab + Docetaxel	62
Arm A: Placebo + Trastuzumab + Docetaxel	33
Arm B: Pertuzumab + Trastuzumab + Docetaxel	45
Arm A: Placebo + Trastuzumab + Docetaxel	4
Arm B: Pertuzumab + Trastuzumab + Docetaxel	3
Arm A: Placebo + Trastuzumab + Docetaxel	0
Arm B: Pertuzumab + Trastuzumab + Docetaxel	1

Week 27

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	54
Arm B: Pertuzumab + Trastuzumab + Docetaxel	51
Arm A: Placebo + Trastuzumab + Docetaxel	35
Arm B: Pertuzumab + Trastuzumab + Docetaxel	43
Arm A: Placebo + Trastuzumab + Docetaxel	3
Arm B: Pertuzumab + Trastuzumab + Docetaxel	5
Arm A: Placebo + Trastuzumab + Docetaxel	0
Arm B: Pertuzumab + Trastuzumab + Docetaxel	0

Week 36

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	45
Arm B: Pertuzumab + Trastuzumab + Docetaxel	46
Arm A: Placebo + Trastuzumab + Docetaxel	28
Arm B: Pertuzumab + Trastuzumab + Docetaxel	43
Arm A: Placebo + Trastuzumab + Docetaxel	3
Arm B: Pertuzumab + Trastuzumab + Docetaxel	4
Arm A: Placebo + Trastuzumab + Docetaxel	0
Arm B: Pertuzumab + Trastuzumab + Docetaxel	1

Week 45

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	34
Arm B: Pertuzumab + Trastuzumab + Docetaxel	36
Arm A: Placebo + Trastuzumab + Docetaxel	29
Arm B: Pertuzumab + Trastuzumab + Docetaxel	43
Arm A: Placebo + Trastuzumab + Docetaxel	5
Arm B: Pertuzumab + Trastuzumab + Docetaxel	3
Arm A: Placebo + Trastuzumab + Docetaxel	0
Arm B: Pertuzumab + Trastuzumab + Docetaxel	0

Week 54

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	26
Arm B: Pertuzumab + Trastuzumab + Docetaxel	38
Arm A: Placebo + Trastuzumab + Docetaxel	27
Arm B: Pertuzumab + Trastuzumab + Docetaxel	34
Arm A: Placebo + Trastuzumab + Docetaxel	4
Arm B: Pertuzumab + Trastuzumab + Docetaxel	3
Arm A: Placebo + Trastuzumab + Docetaxel	0
Arm B: Pertuzumab + Trastuzumab + Docetaxel	0

Week 63

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	21
Arm B: Pertuzumab + Trastuzumab + Docetaxel	30
Arm A: Placebo + Trastuzumab + Docetaxel	17
Arm B: Pertuzumab + Trastuzumab + Docetaxel	33
Arm A: Placebo + Trastuzumab + Docetaxel	6
Arm B: Pertuzumab + Trastuzumab + Docetaxel	3
Arm A: Placebo + Trastuzumab + Docetaxel	0
Arm B: Pertuzumab + Trastuzumab + Docetaxel	0

Week 72

Group	Value	95% CI
Arm A: Placebo + Trastuzumab + Docetaxel	17
Arm B: Pertuzumab + Trastuzumab + Docetaxel	26
Arm A: Placebo + Trastuzumab + Docetaxel	15
Arm B: Pertuzumab + Trastuzumab + Docetaxel	31
Arm A: Placebo + Trastuzumab + Docetaxel	5
Arm B: Pertuzumab + Trastuzumab + Docetaxel	4
Arm A: Placebo + Trastuzumab + Docetaxel	0
Arm B: Pertuzumab + Trastuzumab + Docetaxel	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug until 42 days after last dose of study drug (up to 4 years, 4 months). At final analysis, the median [range] time on study treatment with placebo or pertuzumab per arm was: Arm A - Placebo: 52.3 [3-207] weeks; Arm B - Pertuzumab: 66.1 [3-225] weeks; Arm A - Crossover to Pertuzumab: 18.1 [12-24] weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm A: Placebo + Trastuzumab + Docetaxel

Serious: 23/120 (19%)

Deaths: 50/120

Arm B: Pertuzumab + Trastuzumab + Docetaxel

Serious: 30/122 (25%)

Deaths: 40/122

Arm A: Crossover to Pertuzumab + Trastuzumab + Docetaxel

Serious: 1/12 (8%)

Deaths: 0/12

Serious adverse events (25 terms)

Reaction	System	Arm A: Placebo + Trastuzum…	Arm B: Pertuzumab + Trastu…	Arm A: Crossover to Pertuz…
Neutropenia	Blood and lymphatic system disorders	—	—	—
Pneumonia	Infections and infestations	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—
Cardiac tamponade	Cardiac disorders	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Ventricular arrhythmia	Cardiac disorders	—	—	—
Ascites	Gastrointestinal disorders	—	—	—
Oesophagitis	Gastrointestinal disorders	—	—	—
Death	General disorders	—	—	—
Liver injury	Hepatobiliary disorders	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Fracture	Injury, poisoning and procedural complications	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—
Blood glucose increased	Investigations	—	—	—
Hyperuricaemia	Metabolism and nutrition disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Metrorrhagia	Reproductive system and breast disorders	—	—	—
Pelvic prolapse	Reproductive system and breast disorders	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—
Large intestine polyp	Gastrointestinal disorders	—	—	—
Peripheral arterial occlusive disease	Vascular disorders	—	—	—
Osteomyelitis	Infections and infestations	—	—	—
Soft tissue infection	Infections and infestations	—	—	—
Gastrointestinal carcinoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—

Other adverse events (56 terms — click to expand)

Reaction	System	Arm A: Placebo + Trastuzum…	Arm B: Pertuzumab + Trastu…	Arm A: Crossover to Pertuz…
Leukopenia	Blood and lymphatic system disorders	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—
Pyrexia	General disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Asthenia	General disorders	—	—	—
Pain	General disorders	—	—	—
Oedema peripheral	General disorders	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Weight increased	Investigations	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Nail discolouration	Skin and subcutaneous tissue disorders	—	—	—
Blood bilirubin increased	Investigations	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—
Hypertension	Vascular disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Malaise	General disorders	—	—	—
Blood creatinine increased	Investigations	—	—	—
Weight decreased	Investigations	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Mouth ulceration	Gastrointestinal disorders	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Influenza like illness	General disorders	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Headache	Nervous system disorders	—	—	—

Most-reported serious reactions: Neutropenia, Pneumonia, Febrile neutropenia, Leukopenia, Cardiac tamponade, Alanine aminotransferase increased, Ventricular arrhythmia, Ascites.

Data from ClinicalTrials.gov NCT02896855 adverse events section.

Sponsor's own description

This Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial in China will evaluate the efficacy and safety of pertuzumab + trastuzumab + docetaxel compared with placebo + trastuzumab + docetaxel in participants with previously untreated HER2-positive metastatic breast cancer.

Publications & conference data

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

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
Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): a phase III, randomized, double-blind, placebo-controlled study.
Xu B, Li W, Zhang Q, Shao Z, et al · · 2020 · cited 38× · PMID 32564260 · DOI 10.1007/s10549-020-05728-w
Photodynamic Therapy and Hyperthermia in Combination Treatment-Neglected Forces in the Fight against Cancer.
Bienia A, Wiecheć-Cudak O, Murzyn AA, Krzykawska-Serda M. · · 2021 · cited 36× · PMID 34452108 · DOI 10.3390/pharmaceutics13081147
Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): final analysis of a phase III, randomized, double-blind, placebo-controlled study.
Xu B, Li W, Zhang Q, Li Q, et al · · 2023 · cited 24× · PMID 36463547 · DOI 10.1007/s10549-022-06775-1
Cardiotoxicity of breast cancer drug treatments.
Haque M, Atallah N, Patke R, Harris AE, et al · · 2025 · cited 2× · PMID 40090070 · DOI 10.1016/j.tranon.2025.102352

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NCT07415031 — A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies · Phase 2 · not yet recruiting
NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure · Phase 2 · recruiting
NCT07487896 — A Study of YL201 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Esopha · Phase 3 · not yet recruiting

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Hoffmann-La Roche trials

Trials by the same sponsor.

NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
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 NCT02896855 (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: 16 December 2021

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/NCT02896855.

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