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Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto) (GeparSepto)

Primary Purpose

Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II, Breast Cancer Female NOS

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
nab-Paclitaxel
Paclitaxel
Sponsored by
German Breast Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tubular Breast Cancer Stage II focused on measuring GeparSepto, GBG 69, GBG, German Breast Group, neo-adjuvant, GBG Forschungs GmbH, Tubular breast cancer stage II, Mucinous breast cancer stage II, Invasive ductal breast cancer, Tubular breast cancer stage III, HER-2 positive breast cancer, Inflammatory breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients will be eligible for study participation only if they comply with the following criteria:

  • Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures.
  • Complete baseline documentation must be sent to GBG Forschungs GmbH.
  • Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration alone is not sufficient. Incisional biopsy is not allowed. In case of bilateral cancer, the investigator has to decide prospectively which side will be evaluated for the primary endpoint.
  • Tumor lesion in the breast with a palpable size of >= 2 cm or a sonographical size of >= 1 cm in maximum diameter. The lesion has to be measurable in two dimensions, preferably by sonography. In case of inflammatory disease, the extent of inflammation can be used as measurable lesion.
  • Patients must be in the following stages of disease:

    • - cT2 - cT4a-d or
    • cT1c and cN+ or
    • - cT1c and pNSLN+ or
    • - cT1c and ER-neg and PR-neg or
    • - cT1c and Ki67 > 20%
    • - cT1c and HER2-pos
    • In patients with multifocal or multicentric breast cancer, the largest lesion should be measured.
  • Centrally confirmed ER/PR/HER-2, Ki-67 and SPARC status detected on core biopsy. ER/PR positive is defined as >1% stained cells and HER2-positive is defined as IHC 3+ or in-situ hybridisation (ISH) ratio >2.0. Formalin-fixed, paraffin-embedded (FFPE) breast tissue from core biopsy has therefore to be sent to the Dept. of Pathology at the Charité, Berlin prior to randomization.
  • Age >= 18 years.
  • Karnofsky Performance status index >= 80%.
  • Normal cardiac function must be confirmed by ECG and cardiac ultrasound (LVEF or shortening fraction) within 3 months prior to randomization. Results must be above the normal limit of the institution. For patients with HER2-positive tumors LVEF must be >= 55%.
  • Laboratory requirements:
  • Hematology
  • - Absolute neutrophil count (ANC) >= 2.0 x 109 / L and

    • Platelets >= 100 x 109 / L and
    • Hemoglobin >= 10 g/dL (>= 6.2 mmol/L)
  • Hepatic function
  • - Total bilirubin < 1.5x UNL and

    • ASAT (SGOT) and ALAT (SGPT) <= 1.5x UNL and
    • Alkaline phosphatase <= 2.5x UNL.
  • Negative pregnancy test (urine or serum) within 14 days prior to randomization for all women of childbearing potential.
  • Complete staging work-up within 3 months prior to randomization. All patients must have bilateral mammography, breast ultrasound (<= 21 days), breast MRI (optional), chest X-ray (PA and lateral), abdominal ultrasound or CT scan or MRI, and bone scan done. In case of positive bone scan, bone X-ray is mandatory. Other tests may be performed as clinically indicated.
  • Patients must be available and compliant for central diagnostics, treatment and follow-up.

Exclusion Criteria:

  • Prior chemotherapy for any malignancy.
  • Prior radiation therapy for breast cancer.
  • Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.
  • Inadequate general condition (not fit for anthracycline-taxane-targeted agents-based chemotherapy).
  • Previous malignant disease without being disease-free for less than 5 years (except CIS of the cervix and non-melanomatous skin cancer).
  • Known or suspected congestive heart failure (>NYHA I) and / or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, uncontrolled or poorly controlled arterial hypertension (i.e. BP >160 / 90 mm Hg under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease.
  • History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.
  • Persons who have been admitted to an institution by order of jurisdictional or governmental grounds.
  • Pre-existing motor or sensory neuropathy of grade 2 or more by NCI-CTC criteria v 4.0.
  • Currently active infection.
  • Definite contraindications for the use of corticosteroids.
  • Known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol.
  • Concurrent treatment with:
  • - chronic corticosteroids unless initiated > 6 months prior to study entry and at low dose (10 mg or less methylprednisolone or equivalent).
  • - sex hormones. Prior treatment must be stopped before study entry.
  • - other experimental drugs or any other anti-cancer therapy.
  • Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.
  • Male patients.

Sites / Locations

  • Helios-Klinikum Berlin-Buch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nab-Paclitaxel

Paclitaxel

Arm Description

nab-Paclitaxel (125 mg/m² weekly, infusion) is applicated for 12 weeks, followed by epirubicin and cyclophosphamide, applicated 4 cycles 3-weekly . In case of HER2-positive tumor patients receive tarstuzumab and pertuzumab 3-weekly during all cycles.

Paclitaxel (80 mg/m² weekly, infusion) is applicated for 12 weeks, followed by epirubicin and cyclophosphamide, applicated 4 cycles 3-weekly . In case of HER2-positive tumor patients receive tarstuzumab and pertuzumab 3-weekly during all cycles.

Outcomes

Primary Outcome Measures

Pathological complete response (pCR=ypT0 ypN0) rates of neoadjuvant treatment of nab-paclitaxel with solvent-based paclitaxel as part of neoadjuvant treatment of operable or locally advanced primary breast cancer.
No microscopic evidence of residual invasive or non-invasive viable tumor cells in all resected specimens of the breast and axilla. Pathological response will be assessed considering all removed breast and lymphatic tissues from all surgeries. The primary endpoint will be summarized as pathological complete remission rate for each treatment group.

Secondary Outcome Measures

Rates of ypT0/is ypN0; ypT0 ypN0/+; ypT0/is ypN0/+; ypT(any) ypN0, and regression grade
Response (by physical examination, imaging response, breast conservation) will also be summarized as rates in each treatment group.
Clinical and imaging response
To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests (sonography, mammography, or MRI) after treatment in both arms.
Tolerability and safety
Descriptive statistics for the 4 treatments (each taxane +/- anti-HER2-treatment) will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.
pCR rates per arm
To assess clinical response rate after taxane in both groups.
Breast conservation rate
To determine the breast conservation rate after each treatment.
Onset of grade 3 neuropathy
To assess the time of onset of grade 3 neuropathy.
Resolution of grade 3/4 neuropathy
To assess the time of resolution of grade 3/4 neuropathy to at least grade 1.
Regional recurrence free survival (RRFS) in patients with initial node-positive axilla
To assess regional recurrence free survival (RRFS) in patients with initial node-positive axilla converted to negative at surgery and treated with sentinel node biopsy alone.
pCR rate and local recurrence free survival (LRFS) in patients with a clinical complete response (cCR) and a negative core biopsy
To determine the pCR rate and local recurrence free survival (LRFS) in patients with a clinical complete response (cCR) and a negative core biopsy before surgery.
Examination and comparison of molecular markers
To examine and compare pre-specified molecular markers such as SPARC, gp60, calveoline 1 and other markers potentially differentially predicting efficacy of nab-paclitaxel and solvent-based paclitaxel on core biopsies before, during and after chemotherapy. The aim is to identify potential predictive short and long term parameters.
CTC Substudy
To assess, characterize, and correlate circulating tumor cells and proteins with the effect of treatment.
Pharmacogenetic substudy
To correlate Single Nucleotide Polymorphisms (SNPs) of genes with the associated toxicity and histologically assessed treatment effect.
Ovarian substudy
To assess ovarian function measured by amenorrhea rate in correlation with changes in E2, FSH, LH , Anti-Müller Hormone, ultrasound-follicle count in patients aged <45 years.
Loco-regional invasive recurrence free survival (LRRFS) in both arms and according to stratified subpopulations.
LRRFS is defined as the time period between registration and first event and will be analyzed after the end of the study by referring to data from GBG patient's registry.
Distant-disease-free survival (DDFS) in both arms and according to stratified subpopulations.
DDFS is defined as the time period between registration and first event and will be analyzed after the end of the study by referring to data from GBG patient's registry.
Invasive disease-free survival (IDFS) in both arms and according to stratified subpopulations.
IDFS is defined as the time period between registration and first event and will be analyzed after the end of the study by referring to data from GBG patient's registry.
Overall survival (OS) in both arms and according to stratified subpopulations.
OS is defined as the time period between registration and first event and will be analyzed after the end of the study by referring to data from GBG patient's registry.
Surgical substudy in patients with high probability for pCR
If it can be shown at an interim analysis that the positive predictive value for a pCR of a negative (>=3) core biopsies before surgery in patients with complete clinical response is >90%, these patients might opt for having no further breast surgery.

Full Information

First Posted
April 18, 2012
Last Updated
August 4, 2020
Sponsor
German Breast Group
Collaborators
Celgene Corporation, Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT01583426
Brief Title
Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto)
Acronym
GeparSepto
Official Title
A Randomized Phase III Trial Comparing Nanoparticle-based Paclitaxel With Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Patients With Early Breast Cancer (GeparSepto)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German Breast Group
Collaborators
Celgene Corporation, Roche Pharma AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6 cycles of TAC based on previous large scale studies. Treatment of patients with HER2-positive disease should include also simultaneous application of trastuzumab. Solvent-based taxanes (paclitaxel, docetaxel) cause severe toxicities not only by the active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane®) is a solvent-free formulation of paclitaxel encapsulated in albumin. It does not require premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated hypersensitivity reactions. This new formulation improves safety profile, allows higher dosing with shorter infusion duration, and produces higher tumor drug concentration. As neoadjuvant treatment does not only allow to compare competing treatment approaches with a very high quality (homogenous treatment population, precise assessment of response by histological assessment), but also to identify predictive markers, this trial will compare weekly nab-paclitaxel with solvent-based paclitaxel at their currently optimal doses. In case of HER2-positive tumor status patients receive Pertuzumab and Trastuzumab additionally.
Detailed Description
Primary Objectives: To compare the pathological complete response (pCR=ypT0 ypN0) rates of neoadjuvant treatment of nab-paclitaxel with solvent-based paclitaxel as part of neoadjuvant treatment of operable or locally advanced primary breast cancer Secondary Objectives: To assess the pCR rates per arm separately for the stratified subpopulations. To determine the rates of ypT0/is ypN0; ypT0 ypN0/+; ypT0/is ypN0/+; ypT(any) ypN0; and regression grades. To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests (sonography, mammography, or MRI) after treatment in both arms. To assess clinical response rate after taxane in both groups To determine the breast conservation rate after each treatment. To assess the toxicity and compliance. To assess the time of onset of grade 3 neuropathy To assess the time of resolution of grade 3/4 neuropathy to at least grade 1 To determine loco-regional invasive recurrence free survival (LRRFS), distant-disease-free survival (DDFS), invasive disease-free survival (IDFS), and overall survival (OS) in both arms and according to stratified subpopulations. To assess regional recurrence free survival (RRFS) in patients with initial node-positive axilla converted to negative at surgery and treated with sentinel node biopsy alone. To determine the pCR rate and local recurrence free survival (LRFS) in patients with a clinical complete response (cCR) and a negative core biopsy before surgery. To examine and compare pre-specified molecular markers such as SPARC, gp60, calveoline 1 and other markers potentially differentially predicting efficacy of nab-paclitaxel and solvent-based paclitaxel on core biopsies before, during and after chemotherapy. Objectives of Substudies: To assess, characterize, and correlate circulating tumor cells and proteins with the effect of treatment (CTC Substudy). To correlate Single Nucleotide Polymorphisms (SNPs) of genes with the associated toxicity and histologically assessed treatment effect (Pharmacogenetic substudy) To assess ovarian function measured by amenorrhea rate in correlation with changes in E2, FSH, LH , Anti-Müller Hormone, ultrasound-follicle count in patients aged < 45 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II, Breast Cancer Female NOS, Invasive Ductal Breast Cancer, Tubular Breast Cancer Stage III, HER-2 Positive Breast Cancer, Inflammatory Breast Cancer Stage IV, Inflammatory Breast Cancer
Keywords
GeparSepto, GBG 69, GBG, German Breast Group, neo-adjuvant, GBG Forschungs GmbH, Tubular breast cancer stage II, Mucinous breast cancer stage II, Invasive ductal breast cancer, Tubular breast cancer stage III, HER-2 positive breast cancer, Inflammatory breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nab-Paclitaxel
Arm Type
Experimental
Arm Description
nab-Paclitaxel (125 mg/m² weekly, infusion) is applicated for 12 weeks, followed by epirubicin and cyclophosphamide, applicated 4 cycles 3-weekly . In case of HER2-positive tumor patients receive tarstuzumab and pertuzumab 3-weekly during all cycles.
Arm Title
Paclitaxel
Arm Type
Active Comparator
Arm Description
Paclitaxel (80 mg/m² weekly, infusion) is applicated for 12 weeks, followed by epirubicin and cyclophosphamide, applicated 4 cycles 3-weekly . In case of HER2-positive tumor patients receive tarstuzumab and pertuzumab 3-weekly during all cycles.
Intervention Type
Drug
Intervention Name(s)
nab-Paclitaxel
Other Intervention Name(s)
Abraxane
Intervention Description
nab-Paclitaxel 125 mg/m² weekly for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel 80 mg/m² weekly for 12 weeks
Primary Outcome Measure Information:
Title
Pathological complete response (pCR=ypT0 ypN0) rates of neoadjuvant treatment of nab-paclitaxel with solvent-based paclitaxel as part of neoadjuvant treatment of operable or locally advanced primary breast cancer.
Description
No microscopic evidence of residual invasive or non-invasive viable tumor cells in all resected specimens of the breast and axilla. Pathological response will be assessed considering all removed breast and lymphatic tissues from all surgeries. The primary endpoint will be summarized as pathological complete remission rate for each treatment group.
Time Frame
24 weeks (time window + 3 weeks)
Secondary Outcome Measure Information:
Title
Rates of ypT0/is ypN0; ypT0 ypN0/+; ypT0/is ypN0/+; ypT(any) ypN0, and regression grade
Description
Response (by physical examination, imaging response, breast conservation) will also be summarized as rates in each treatment group.
Time Frame
24 weeks (time window + 3 weeks)
Title
Clinical and imaging response
Description
To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests (sonography, mammography, or MRI) after treatment in both arms.
Time Frame
24 weeks (time window + 3 weeks)
Title
Tolerability and safety
Description
Descriptive statistics for the 4 treatments (each taxane +/- anti-HER2-treatment) will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.
Time Frame
during treatment (24 weeks)
Title
pCR rates per arm
Description
To assess clinical response rate after taxane in both groups.
Time Frame
24 weeks (time window + 3 weeks)
Title
Breast conservation rate
Description
To determine the breast conservation rate after each treatment.
Time Frame
24 weeks (time window + 3 weeks)
Title
Onset of grade 3 neuropathy
Description
To assess the time of onset of grade 3 neuropathy.
Time Frame
24 weeks (time window + 3 weeks)
Title
Resolution of grade 3/4 neuropathy
Description
To assess the time of resolution of grade 3/4 neuropathy to at least grade 1.
Time Frame
24 weeks (time window + 3 weeks)
Title
Regional recurrence free survival (RRFS) in patients with initial node-positive axilla
Description
To assess regional recurrence free survival (RRFS) in patients with initial node-positive axilla converted to negative at surgery and treated with sentinel node biopsy alone.
Time Frame
until event occurs - no event for cured patients
Title
pCR rate and local recurrence free survival (LRFS) in patients with a clinical complete response (cCR) and a negative core biopsy
Description
To determine the pCR rate and local recurrence free survival (LRFS) in patients with a clinical complete response (cCR) and a negative core biopsy before surgery.
Time Frame
24 weeks (time frame + 3 weeks)
Title
Examination and comparison of molecular markers
Description
To examine and compare pre-specified molecular markers such as SPARC, gp60, calveoline 1 and other markers potentially differentially predicting efficacy of nab-paclitaxel and solvent-based paclitaxel on core biopsies before, during and after chemotherapy. The aim is to identify potential predictive short and long term parameters.
Time Frame
Baseline, 12 weeks and 24 weeks (time frame + 3 weeks)
Title
CTC Substudy
Description
To assess, characterize, and correlate circulating tumor cells and proteins with the effect of treatment.
Time Frame
Baseline, 12 weeks and 24 weeks (time frame + 3 weeks)
Title
Pharmacogenetic substudy
Description
To correlate Single Nucleotide Polymorphisms (SNPs) of genes with the associated toxicity and histologically assessed treatment effect.
Time Frame
Baseline
Title
Ovarian substudy
Description
To assess ovarian function measured by amenorrhea rate in correlation with changes in E2, FSH, LH , Anti-Müller Hormone, ultrasound-follicle count in patients aged <45 years.
Time Frame
Baseline, 6 months, 12 months, 18 months, 24 months 30 months
Title
Loco-regional invasive recurrence free survival (LRRFS) in both arms and according to stratified subpopulations.
Description
LRRFS is defined as the time period between registration and first event and will be analyzed after the end of the study by referring to data from GBG patient's registry.
Time Frame
5 years
Title
Distant-disease-free survival (DDFS) in both arms and according to stratified subpopulations.
Description
DDFS is defined as the time period between registration and first event and will be analyzed after the end of the study by referring to data from GBG patient's registry.
Time Frame
5 years
Title
Invasive disease-free survival (IDFS) in both arms and according to stratified subpopulations.
Description
IDFS is defined as the time period between registration and first event and will be analyzed after the end of the study by referring to data from GBG patient's registry.
Time Frame
5 years
Title
Overall survival (OS) in both arms and according to stratified subpopulations.
Description
OS is defined as the time period between registration and first event and will be analyzed after the end of the study by referring to data from GBG patient's registry.
Time Frame
5 years
Title
Surgical substudy in patients with high probability for pCR
Description
If it can be shown at an interim analysis that the positive predictive value for a pCR of a negative (>=3) core biopsies before surgery in patients with complete clinical response is >90%, these patients might opt for having no further breast surgery.
Time Frame
Baseline, after 4 cycles and before surgery (time frame + 3 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will be eligible for study participation only if they comply with the following criteria: Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures. Complete baseline documentation must be sent to GBG Forschungs GmbH. Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration alone is not sufficient. Incisional biopsy is not allowed. In case of bilateral cancer, the investigator has to decide prospectively which side will be evaluated for the primary endpoint. Tumor lesion in the breast with a palpable size of >= 2 cm or a sonographical size of >= 1 cm in maximum diameter. The lesion has to be measurable in two dimensions, preferably by sonography. In case of inflammatory disease, the extent of inflammation can be used as measurable lesion. Patients must be in the following stages of disease: - cT2 - cT4a-d or cT1c and cN+ or - cT1c and pNSLN+ or - cT1c and ER-neg and PR-neg or - cT1c and Ki67 > 20% - cT1c and HER2-pos In patients with multifocal or multicentric breast cancer, the largest lesion should be measured. Centrally confirmed ER/PR/HER-2, Ki-67 and SPARC status detected on core biopsy. ER/PR positive is defined as >1% stained cells and HER2-positive is defined as IHC 3+ or in-situ hybridisation (ISH) ratio >2.0. Formalin-fixed, paraffin-embedded (FFPE) breast tissue from core biopsy has therefore to be sent to the Dept. of Pathology at the Charité, Berlin prior to randomization. Age >= 18 years. Karnofsky Performance status index >= 80%. Normal cardiac function must be confirmed by ECG and cardiac ultrasound (LVEF or shortening fraction) within 3 months prior to randomization. Results must be above the normal limit of the institution. For patients with HER2-positive tumors LVEF must be >= 55%. Laboratory requirements: Hematology - Absolute neutrophil count (ANC) >= 2.0 x 109 / L and Platelets >= 100 x 109 / L and Hemoglobin >= 10 g/dL (>= 6.2 mmol/L) Hepatic function - Total bilirubin < 1.5x UNL and ASAT (SGOT) and ALAT (SGPT) <= 1.5x UNL and Alkaline phosphatase <= 2.5x UNL. Negative pregnancy test (urine or serum) within 14 days prior to randomization for all women of childbearing potential. Complete staging work-up within 3 months prior to randomization. All patients must have bilateral mammography, breast ultrasound (<= 21 days), breast MRI (optional), chest X-ray (PA and lateral), abdominal ultrasound or CT scan or MRI, and bone scan done. In case of positive bone scan, bone X-ray is mandatory. Other tests may be performed as clinically indicated. Patients must be available and compliant for central diagnostics, treatment and follow-up. Exclusion Criteria: Prior chemotherapy for any malignancy. Prior radiation therapy for breast cancer. Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment. Inadequate general condition (not fit for anthracycline-taxane-targeted agents-based chemotherapy). Previous malignant disease without being disease-free for less than 5 years (except CIS of the cervix and non-melanomatous skin cancer). Known or suspected congestive heart failure (>NYHA I) and / or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, uncontrolled or poorly controlled arterial hypertension (i.e. BP >160 / 90 mm Hg under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease. History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent. Persons who have been admitted to an institution by order of jurisdictional or governmental grounds. Pre-existing motor or sensory neuropathy of grade 2 or more by NCI-CTC criteria v 4.0. Currently active infection. Definite contraindications for the use of corticosteroids. Known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol. Concurrent treatment with: - chronic corticosteroids unless initiated > 6 months prior to study entry and at low dose (10 mg or less methylprednisolone or equivalent). - sex hormones. Prior treatment must be stopped before study entry. - other experimental drugs or any other anti-cancer therapy. Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry. Male patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Untch, Prof MD
Organizational Affiliation
AGO, ASCO, DKG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helios-Klinikum Berlin-Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25199759
Citation
Loibl S, von Minckwitz G, Schneeweiss A, Paepke S, Lehmann A, Rezai M, Zahm DM, Sinn P, Khandan F, Eidtmann H, Dohnal K, Heinrichs C, Huober J, Pfitzner B, Fasching PA, Andre F, Lindner JL, Sotiriou C, Dykgers A, Guo S, Gade S, Nekljudova V, Loi S, Untch M, Denkert C. PIK3CA mutations are associated with lower rates of pathologic complete response to anti-human epidermal growth factor receptor 2 (her2) therapy in primary HER2-overexpressing breast cancer. J Clin Oncol. 2014 Oct 10;32(29):3212-20. doi: 10.1200/JCO.2014.55.7876. Epub 2014 Sep 8.
Results Reference
background
PubMed Identifier
20697801
Citation
Huober J, von Minckwitz G, Denkert C, Tesch H, Weiss E, Zahm DM, Belau A, Khandan F, Hauschild M, Thomssen C, Hogel B, Darb-Esfahani S, Mehta K, Loibl S. Effect of neoadjuvant anthracycline-taxane-based chemotherapy in different biological breast cancer phenotypes: overall results from the GeparTrio study. Breast Cancer Res Treat. 2010 Nov;124(1):133-40. doi: 10.1007/s10549-010-1103-9. Epub 2010 Aug 10.
Results Reference
background
PubMed Identifier
19470941
Citation
Gradishar WJ, Krasnojon D, Cheporov S, Makhson AN, Manikhas GM, Clawson A, Bhar P. Significantly longer progression-free survival with nab-paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer. J Clin Oncol. 2009 Aug 1;27(22):3611-9. doi: 10.1200/JCO.2008.18.5397. Epub 2009 May 26. Erratum In: J Clin Oncol. 2011 Jul 1;29(19):2739.
Results Reference
background
PubMed Identifier
26869049
Citation
Untch M, Jackisch C, Schneeweiss A, Conrad B, Aktas B, Denkert C, Eidtmann H, Wiebringhaus H, Kummel S, Hilfrich J, Warm M, Paepke S, Just M, Hanusch C, Hackmann J, Blohmer JU, Clemens M, Darb-Esfahani S, Schmitt WD, Dan Costa S, Gerber B, Engels K, Nekljudova V, Loibl S, von Minckwitz G; German Breast Group (GBG); Arbeitsgemeinschaft Gynakologische Onkologie-Breast (AGO-B) Investigators. Nab-paclitaxel versus solvent-based paclitaxel in neoadjuvant chemotherapy for early breast cancer (GeparSepto-GBG 69): a randomised, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):345-356. doi: 10.1016/S1470-2045(15)00542-2. Epub 2016 Feb 8. Erratum In: Lancet Oncol. 2016 Jul;17 (7):e270.
Results Reference
result
PubMed Identifier
34252375
Citation
Denkert C, Seither F, Schneeweiss A, Link T, Blohmer JU, Just M, Wimberger P, Forberger A, Tesch H, Jackisch C, Schmatloch S, Reinisch M, Solomayer EF, Schmitt WD, Hanusch C, Fasching PA, Lubbe K, Solbach C, Huober J, Rhiem K, Marme F, Reimer T, Schmidt M, Sinn BV, Janni W, Stickeler E, Michel L, Stotzer O, Hahnen E, Furlanetto J, Seiler S, Nekljudova V, Untch M, Loibl S. Clinical and molecular characteristics of HER2-low-positive breast cancer: pooled analysis of individual patient data from four prospective, neoadjuvant clinical trials. Lancet Oncol. 2021 Aug;22(8):1151-1161. doi: 10.1016/S1470-2045(21)00301-6. Epub 2021 Jul 9.
Results Reference
derived
PubMed Identifier
28315068
Citation
Furlanetto J, Jackisch C, Untch M, Schneeweiss A, Schmatloch S, Aktas B, Denkert C, Wiebringhaus H, Kummel S, Warm M, Paepke S, Just M, Hanusch C, Hackmann J, Blohmer JU, Clemens M, Costa SD, Gerber B, Nekljudova V, Loibl S, von Minckwitz G. Efficacy and safety of nab-paclitaxel 125 mg/m2 and nab-paclitaxel 150 mg/m2 compared to paclitaxel in early high-risk breast cancer. Results from the neoadjuvant randomized GeparSepto study (GBG 69). Breast Cancer Res Treat. 2017 Jun;163(3):495-506. doi: 10.1007/s10549-017-4200-1. Epub 2017 Mar 17.
Results Reference
derived
Links:
URL
https://www.gbg.de/de/studien/
Description
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Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto)

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