Download PDF

Clinical Trial Results:
A randomized phase III trial comparing two dose-dense, dose-intensified approaches (iddEPC and PM(Cb)) for neoadjuvant treatment of patients with high-risk early breast cancer (GeparOcto)

Summary
EudraCT number	2014-000619-14
Trial protocol	DE
Global end of trial date	30 Jan 2017

Results information
Results version number	v1(current)
This version publication date	09 Mar 2022
First version publication date	09 Mar 2022
Other versions
Summary report(s)	GeparOcto CSR Synopsis

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

GBG84

ISRCTN number

US NCT number

NCT02125344

WHO universal trial number (UTN)

Sponsor organisation name

GBG Forschungs GmbH

Sponsor organisation address

Martin Behaim Str. 12, Neu-Isenburg, Germany, 63263

Public contact

Medicine and Research, GBG Forschungs GmbH , publications@gbg.de

Scientific contact

Medicine and Research, GBG Forschungs GmbH , publications@gbg.de

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

15 Sep 2017

Is this the analysis of the primary completion data?

Yes

Primary completion date

06 Dec 2016

Global end of trial reached?

Yes

Global end of trial date

30 Jan 2017

Was the trial ended prematurely?

Main objective of the trial

To compare the pathological complete response (pCR= ypT0/is ypN0) rates of neoadjuvant treatment with sequential, dose-dense, dose-intensified epirubicin, paclitaxel, and cyclophosphamide (iddETC) vs weekly paclitaxel plus non-pegylated liposomal doxorubicin (plus additional carboplatin in triple-negative breast cancer, PM[Cb]) in patients with high-risk operable or locally advanced breast cancer. Only for those patients randomized for the supportive anemia treatment: To compare the frequency of patients reaching hemoglobin (Hb) levels ≥ 11g/dl 6 weeks after treatment start of a first episode of anemia grade ≥2 (Hb < 10g/dl) between patients receiving supportive treatment for iron deficiency with parental ferric carboxymaltose versus physician’s choice (no supportive treatment, oral iron substitution, erythropoiesis-stimulating agent (ESA), or both).

Protection of trial subjects

The trial protocol including amendments, the patient information and the informed consent were reviewed and approved from a properly constituted IRB/IEC for each site prior to the study start. The trial was in compliance with the International Conference on Harmonization (ICH) - Harmonized Tripartite Guideline for Good Clinical Practice (GCP) (E6), and the Commission Directives in the European Community as well as with the applicable German national laws and regulations, and with Declaration of Helsinki and its revisions in all aspects of preparation, monitoring, reporting, auditing, and archiving.

Background therapy

Carboplatin for triple-negative breast cancer and trastuzumab for HER2-positive disease

Evidence for comparator

Standard of Care (SoC)

Actual start date of recruitment

01 Dec 2014

Long term follow-up planned

Yes

Long term follow-up rationale

Scientific research

Long term follow-up duration

10 Years

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 945

Worldwide total number of subjects

945

EEA total number of subjects

945

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

886

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Between 12/2014 and 06/2016, 1204 patients were screened, 961 patients were randomised, and 945 started treatment. Treatment was completed by 393/470 (83.6%) patients in the iddEPC and 313/475 (65.9%) in the PM(Cb) arm.

Screening details

Patients of at least 18 years of age with previously untreated, unilateral or bilateral, non-metastatic invasive breast cancer (BC); with cT1c-cT4a-d and centrally assessed human epidermal growth factor receptor (HER)2-positive BC or TNBC were eligible, irrespective of nodal status, luminal B-like tumours only if pN-positive.

Period 1 title

overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

iddEPC

Arm description

A total of 480 patients were randomised to receive sequential treatment with intense dose-dense epirubicin, paclitaxel, and cyclophosphamide (iddEPC), 470 started treatment, 393 completed treatment, and 467 received surgery. Note, the number of patients started treatment is given for "started"

Arm type

Experimental

Investigational medicinal product name

epirubicin

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

150 mg/m², given on day 1 every 2 weeks for 3 cycles

Investigational medicinal product name

cyclophosphamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

2000 mg/m², given on day 1 every 2 weeks for 3 cycles

Investigational medicinal product name

paclitaxel

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

225 mg/m² given every two weeks for 3 cycles

PM(Cb)

Arm description

A total of 481 patients with breast cancer (BC) were randomised to receive weekly treatment with paclitaxel plus non-pegylated liposomal doxorubicin (M, Myocet) with additional carboplatin (PM(Cb) in triple-negative BC (TNBC), 475 started treatment, 313 patients completed treatment regularly, and 471 received surgery. Note, the number of patients started treatment is given for "started".

Arm type

Active comparator

Investigational medicinal product name

paclitaxel

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

80 mg/m², given weekly for 18 weeks

Investigational medicinal product name

non-pegylated liposomal doxorubicin

Investigational medicinal product code

Other name

NPLD (Myocet)

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

20 mg/m², given weekly for 18 weeks

Investigational medicinal product name

carboplatin

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

AUC 1.5, given weekly for 18 weeks

Number of subjects in period 1	iddEPC	PM(Cb)
Started	470	475
Completed	393	313
Not completed	77	162
Adverse event, serious fatal	-	1
Physician decision	10	13
Adverse event, non-fatal	47	114
local progress	3	8
distant metastases	-	1
patient decision	17	25

Baseline characteristics

Top of page

Reporting group title

iddEPC

Reporting group description

Reporting group title

PM(Cb)

Reporting group description

Reporting group values	iddEPC	PM(Cb)	Total
Number of subjects	470	475	945
Age categorical
Units: Subjects
Adults (18-64 years)	439	447	886
From 65-84 years	31	28	59
85 years and over	0	0	0
Gender categorical
Units: Subjects
Female	470	475	945
Male	0	0	0

End points

Top of page

Reporting group title

iddEPC

Reporting group description

Reporting group title

PM(Cb)

Reporting group description

Primary: pCR (ypT0/is ypN0)

Top of page

End point title

pCR (ypT0/is ypN0)

End point description

The primary efficacy endpoint of this study was pathological complete response (pCR=ypT0/is ypN0), defined as no microscopic evidence of residual invasive viable tumor cells in all resected specimens of the breast and axilla.

End point type

Primary

End point timeframe

The entire treatment period was 18 weeks.

End point values	iddEPC	PM(Cb)
Number of subjects analysed	470	475
Units: percent
number (confidence interval 95%)
pCR (ypT0/is ypN0)	48.3 (43.7 to 52.9)	48.0 (43.4 to 52.6)

pCR (ypT0/is ypN0) - absolute diffrences

Statistical analysis description

Analysis of the primary endpoint was based on the modified intent-to-treat (mITT) set including all patients who were randomised and received at least one dose of study medication. The primary endpoint was summarized as pCR rate for each treatment group. Two-sided 95% confidence intervals (CI) were calculated. The difference in the rates of pCR between groups was evaluated as an absolute difference and its 95% CI.

Comparison groups

iddEPC v PM(Cb)

Number of subjects included in analysis

945

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

= 0.979

Method

Chi-squared corrected

Confidence interval

Notes
[1] - Significance was tested with the two-sided continuity corrected χ2-test with significance level of alpha = 0.05. It was pre-planned in the study protocol that, if the superiority test failed to detect a significant difference, the non-inferiority was to be tested.

pCR (ypT0/is ypN0) - absolute diffrences

Comparison groups

iddEPC v PM(Cb)

Number of subjects included in analysis

945

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[2]

P-value

= 0.979

Method

Chi-squared corrected

Parameter type

absolute difference

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-6.7

upper limit

6.1

Notes
[2] - The non-inferiority margin for the pCR rate difference was set to 5%, non-inferiority was to be claimed, if the lower limit of the two-sided 95% CI for the pCR rate difference (PM(Cb) arm minus iddEPC arm) was greater than -5%.

pCR (ypT0/is ypN0) - odds ratio

Statistical analysis description

A multivariate logistic regression analysis was performed for the primary efficacy endpoint pCR to report odds ratios with 95% CI, adjusted for the factors biological subtype, Ki-67, LPBC, age, cT, cN, tumor grading, histological tumor type

Comparison groups

iddEPC v PM(Cb)

Number of subjects included in analysis

945

Analysis specification

Pre-specified

Analysis type

superiority ^[3]

P-value

= 0.931

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.988

Confidence interval

level

95%

sides

2-sided

lower limit

0.75

upper limit

1.31

Notes
[3] - Multivariate logistic regression analysis

Adverse events

Top of page

Timeframe for reporting adverse events

All adverse events occurring during the study treatment period were reported.

Adverse event reporting additional description

AEs are reported per patient during the complete treatment duration for the overall safety population. Non-serious AEs any grade per patient occurring more frequently (> 20%) are presented. Of note, overall number of single AE occurrences per term was not assessed, only per patient; SAEs are reported regardless of causality.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

19.1

Reporting group title

iddEPC

Reporting group description

sequential treatment with intense dose-dense epirubicin, paclitaxel, and cyclophosphamide (iddEPC)

Reporting group title

PM(Cb)

Reporting group description

weekly treatment with paclitaxel (P) plus non-pegylated liposomal doxorubicin (M) with additional carboplatin (Cb) in TNBC (PM(Cb))

Serious adverse events	iddEPC	PM(Cb)
Total subjects affected by serious adverse events
subjects affected / exposed	174 / 470 (37.02%)	171 / 475 (36.00%)
number of deaths (all causes)	0	2
number of deaths resulting from adverse events	0	1
Vascular disorders
Embolism
subjects affected / exposed	2 / 470 (0.43%)	5 / 475 (1.05%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	2 / 470 (0.43%)	4 / 475 (0.84%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	0 / 470 (0.00%)	3 / 475 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	0 / 470 (0.00%)	3 / 475 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	40 / 470 (8.51%)	43 / 475 (9.05%)
occurrences causally related to treatment / all	0 / 40	0 / 43
deaths causally related to treatment / all	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	13 / 470 (2.77%)	3 / 475 (0.63%)
occurrences causally related to treatment / all	0 / 13	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Fatigue
subjects affected / exposed	1 / 470 (0.21%)	4 / 475 (0.84%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Asthenia
subjects affected / exposed	3 / 470 (0.64%)	1 / 475 (0.21%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Immune system disorders
subjects affected / exposed	3 / 470 (0.64%)	1 / 475 (0.21%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Reproductive system and breast disorders
subjects affected / exposed	2 / 470 (0.43%)	0 / 475 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pneumonitis
subjects affected / exposed	2 / 470 (0.43%)	15 / 475 (3.16%)
occurrences causally related to treatment / all	0 / 2	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	4 / 470 (0.85%)	2 / 475 (0.42%)
occurrences causally related to treatment / all	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Psychiatric disorders
subjects affected / exposed	1 / 470 (0.21%)	3 / 475 (0.63%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Investigations
subjects affected / exposed	1 / 470 (0.21%)	1 / 475 (0.21%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Spinal fracture
subjects affected / exposed	0 / 470 (0.00%)	3 / 475 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Ejection fraction decreased
subjects affected / exposed	2 / 470 (0.43%)	1 / 475 (0.21%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Nervous system disorders
subjects affected / exposed	9 / 470 (1.91%)	7 / 475 (1.47%)
occurrences causally related to treatment / all	0 / 9	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Febrile neutropenia
subjects affected / exposed	43 / 470 (9.15%)	10 / 475 (2.11%)
occurrences causally related to treatment / all	0 / 43	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	40 / 470 (8.51%)	0 / 475 (0.00%)
occurrences causally related to treatment / all	0 / 40	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Leukopenia
subjects affected / exposed	26 / 470 (5.53%)	3 / 475 (0.63%)
occurrences causally related to treatment / all	0 / 26	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	9 / 470 (1.91%)	1 / 475 (0.21%)
occurrences causally related to treatment / all	0 / 9	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia
subjects affected / exposed	1 / 470 (0.21%)	6 / 475 (1.26%)
occurrences causally related to treatment / all	0 / 1	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Ear and labyrinth disorders
subjects affected / exposed	0 / 470 (0.00%)	1 / 475 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	3 / 470 (0.64%)	21 / 475 (4.42%)
occurrences causally related to treatment / all	0 / 3	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	5 / 470 (1.06%)	2 / 475 (0.42%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mucosal inflammation
subjects affected / exposed	4 / 470 (0.85%)	2 / 475 (0.42%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	6 / 470 (1.28%)	0 / 475 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stomatitis
subjects affected / exposed	4 / 470 (0.85%)	1 / 475 (0.21%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Hepatobiliary disorders
subjects affected / exposed	1 / 470 (0.21%)	4 / 475 (0.84%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
subjects affected / exposed	0 / 470 (0.00%)	5 / 475 (1.05%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Renal and urinary disorders
subjects affected / exposed	1 / 470 (0.21%)	0 / 475 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	2 / 470 (0.43%)	1 / 475 (0.21%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Pneumonia
subjects affected / exposed	3 / 470 (0.64%)	31 / 475 (6.53%)
occurrences causally related to treatment / all	0 / 3	1 / 31
deaths causally related to treatment / all	0 / 0	1 / 1
Urinary tract infection
subjects affected / exposed	3 / 470 (0.64%)	6 / 475 (1.26%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Infection
subjects affected / exposed	3 / 470 (0.64%)	3 / 475 (0.63%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Device related infection
subjects affected / exposed	1 / 470 (0.21%)	4 / 475 (0.84%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess
subjects affected / exposed	1 / 470 (0.21%)	2 / 475 (0.42%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Atypical pneumonia
subjects affected / exposed	0 / 470 (0.00%)	3 / 475 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	1 / 470 (0.21%)	2 / 475 (0.42%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza
subjects affected / exposed	2 / 470 (0.43%)	1 / 475 (0.21%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	0 / 470 (0.00%)	3 / 475 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypokalaemia
subjects affected / exposed	1 / 470 (0.21%)	2 / 475 (0.42%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	iddEPC	PM(Cb)
Total subjects affected by non serious adverse events
subjects affected / exposed	470 / 470 (100.00%)	475 / 475 (100.00%)
Investigations
Alanine aminotransferase increased
subjects affected / exposed	346 / 470 (73.62%)	234 / 475 (49.26%)
occurrences all number	346	234
Alkaline phosphatase increased
subjects affected / exposed	300 / 470 (63.83%)	182 / 475 (38.32%)
occurrences all number	300	182
Aspartate aminotransferase increased
subjects affected / exposed	208 / 470 (44.26%)	134 / 475 (28.21%)
occurrences all number	208	134
Nervous system disorders
Peripheral sensory neuropathy
subjects affected / exposed	392 / 470 (83.40%)	345 / 475 (72.63%)
occurrences all number	392	345
Headache
subjects affected / exposed	152 / 470 (32.34%)	117 / 475 (24.63%)
occurrences all number	152	117
Blood and lymphatic system disorders
Anemia
subjects affected / exposed	466 / 470 (99.15%)	437 / 475 (92.00%)
occurrences all number	466	437
Leukopenia
subjects affected / exposed	450 / 470 (95.74%)	401 / 475 (84.42%)
occurrences all number	450	401
Neutropenia
subjects affected / exposed	422 / 470 (89.79%)	305 / 475 (64.21%)
occurrences all number	422	305
Thrombopenia
subjects affected / exposed	367 / 470 (78.09%)	145 / 475 (30.53%)
occurrences all number	367	145
General disorders and administration site conditions
Fatigue
Additional description: Fatigue and asthenia
subjects affected / exposed	372 / 470 (79.15%)	342 / 475 (72.00%)
occurrences all number	372	342
Fever
Additional description: Fever without neutropenia
subjects affected / exposed	107 / 470 (22.77%)	146 / 475 (30.74%)
occurrences all number	107	146
Gastrointestinal disorders
Mucositis
subjects affected / exposed	270 / 470 (57.45%)	312 / 475 (65.68%)
occurrences all number	270	312
Nausea
subjects affected / exposed	316 / 470 (67.23%)	236 / 475 (49.68%)
occurrences all number	316	236
Diarrhoea
subjects affected / exposed	191 / 470 (40.64%)	262 / 475 (55.16%)
occurrences all number	191	262
Stomatitis
subjects affected / exposed	156 / 470 (33.19%)	174 / 475 (36.63%)
occurrences all number	156	174
Respiratory, thoracic and mediastinal disorders
Epistaxis
subjects affected / exposed	59 / 470 (12.55%)	132 / 475 (27.79%)
occurrences all number	59	132
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	412 / 470 (87.66%)	421 / 475 (88.63%)
occurrences all number	412	421
Skin reactions
subjects affected / exposed	252 / 470 (53.62%)	364 / 475 (76.63%)
occurrences all number	252	364
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	207 / 470 (44.04%)	103 / 475 (21.68%)
occurrences all number	207	103
Myalgia
subjects affected / exposed	175 / 470 (37.23%)	97 / 475 (20.42%)
occurrences all number	175	97
Infections and infestations
Infection other than pneumonia
subjects affected / exposed	205 / 470 (43.62%)	252 / 475 (53.05%)
occurrences all number	205	252
Metabolism and nutrition disorders
Anorexia
subjects affected / exposed	117 / 470 (24.89%)	88 / 475 (18.53%)
occurrences all number	117	88

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

16 Nov 2015

There was one substantial amendment to the protocol of GeparOcto pertaining to the supportive anemia treatment. As the number of patients requiring supportive treatment for iron deficiency was too low meeting the original threshold of serum ferritin of <300ng/ml during the initial phase of the study, this threshold was changed to <600ng/ml by the amendment.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

http://www.ncbi.nlm.nih.gov/pubmed/30528802
http://www.ncbi.nlm.nih.gov/pubmed/34801353
http://www.ncbi.nlm.nih.gov/pubmed/33191846
http://www.ncbi.nlm.nih.gov/pubmed/32163106
http://www.ncbi.nlm.nih.gov/pubmed/35158789

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Clinical trials

Clinical Trial Results:
A randomized phase III trial comparing two dose-dense, dose-intensified approaches (iddEPC and PM(Cb)) for neoadjuvant treatment of patients with high-risk early breast cancer (GeparOcto)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: pCR (ypT0/is ypN0)

Primary: pCR (ypT0/is ypN0)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A randomized phase III trial comparing two dose-dense, dose-intensified approaches (iddEPC and PM(Cb)) for neoadjuvant treatment of patients with high-risk early breast cancer (GeparOcto)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: pCR (ypT0/is ypN0)

Primary: pCR (ypT0/is ypN0)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
A randomized phase III trial comparing two dose-dense, dose-intensified approaches (iddEPC and PM(Cb)) for neoadjuvant treatment of patients with high-risk early breast cancer (GeparOcto)