Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto)
NCT ID: NCT01583426
Last Updated: 2020-08-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
1229 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-07-31
Study Completion Date
2018-12-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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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
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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nab-Paclitaxel
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.
Group Type
EXPERIMENTAL
nab-Paclitaxel
Intervention Type
DRUG
nab-Paclitaxel 125 mg/m² weekly for 12 weeks
Paclitaxel
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.
Group Type
ACTIVE_COMPARATOR
Paclitaxel
Intervention Type
DRUG
Paclitaxel 80 mg/m² weekly for 12 weeks
Interventions
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nab-Paclitaxel
nab-Paclitaxel 125 mg/m² weekly for 12 weeks
Intervention Type
DRUG
Paclitaxel
Paclitaxel 80 mg/m² weekly for 12 weeks
Intervention Type
DRUG
Other Intervention Names
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Abraxane
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Celgene Corporation
INDUSTRY
Sponsor Role
collaborator
Roche Pharma AG
INDUSTRY
Sponsor Role
collaborator
GBG Forschungs GmbH
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Michael Untch, Prof MD
Role: PRINCIPAL_INVESTIGATOR
AGO, ASCO, DKG
Locations
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Helios-Klinikum Berlin-Buch
Berlin, , Germany
Site Status
Countries
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Germany
References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
RESULT
Fasching PA, Szeto C, Denkert C, Benz S, Weber K, Spilman P, Budczies J, Schneeweiss A, Stickeler E, Schmatloch S, Jackisch C, Karn T, Sinn HP, Warm M, van Mackelenbergh M, Rabizadeh S, Schem C, Heinmoller E, Mueller V, Marme F, Soon-Shiong P, Nekljudova V, Untch M, Loibl S. Inferred Immune-Cell Activity Is an Independent Predictor of HER2-Negative Breast Cancer Prognosis and Response to Paclitaxel-Based Therapy in the GeparSepto Trial. Clin Cancer Res. 2023 Jul 5;29(13):2456-2465. doi: 10.1158/1078-0432.CCR-22-2213.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Related Links
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https://www.gbg.de/de/studien/
Sponsor study homepage
Other Identifiers
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2011-004714-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GBG 69
Identifier Type: -
Identifier Source: org_study_id
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