Breast CancerPhase 3GeparTrioNCT00544765
Docetaxel, Doxorubicin and Cyclophosphamide Versus Vinorelbine and Capecitabine in Patients Not Sufficiently / Sufficiently Responding as Preoperative Treatment of Locally Advanced or Operable Primary Breast Cancer
A Phase 3 study testing TAC and NX in people with Breast Cancer, run by GBG Forschungs GmbH.
Trial summary
Primary objective of the study in patients without a sufficient sonographic response (i.e. iNC) to 2 cycles of TAC as preoperative treatment of operable (T>/= 2cm, N0-2,M0) primary breast cancer: To determine the response rate determined by sonography (iRR = iCR+iPR) of further 4 cycles of docetaxel, doxorubicin and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- TAC and NX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,014 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Feb 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
- Complete baseline documentation sent to SKM CRS.
- Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration 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 in maximum diameter. The leasion has to be measurable in two-dimensions by sonography. In case of inflammatory disease the extent of inflammation can be used as measurable lesion. The following tumor stages are eligible:
- Palpable breast tumor size of > 2 cm without involvement of the skin or muscle or evidence of inflammatory disease (T2-3). Clinical N0-2. (Study population I)
- Primary tumor with clinical involvement of skin or muscle or clinically evidence of inflammatory breast cancer (T4 a-d) or clinical N3 including supraclavicular nodes. (Study population II). In patients with multifocal or multicentric breast cancer, the largest lesion should be measured.
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- Age > 18 years.
- Karnofsky Performance status index > 80%.
- Normal cardiac function must be confirmed by LVEF or shortening fraction (echocardiography or MUGA scan respectively) within 3 months prior to registration. The result must be above the normal limit of the institution.
- Laboratory requirements (within 14 days prior to registration):
- Hematology:
- Neutrophils > 2.0 x 109/L and
- Platelets > 100 x 109/L and
- Hemoglobin > 10 g/dL
- Hepatic function:
- Total bilirubin < 1 x UNL and
- ASAT (SGOT) and ALAT (SGPT) < 2.5 x UNL and
- Alkaline phosphatase < 5 UNL. Patients with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study.
- Renal function:
- Creatinine < 175 µmol/L (2 mg/dL)
- Tissue block centrally available for further biological tests.
- Negative pregnancy test (urine or serum) within 14 days prior to registration for all women of childbearing potential.
- Complete staging work-up within 3 months prior to registration. All patients must have bilateral mammography, breast ultrasound, breast MRI (optional), chest X-ray (PA and lateral), abdominal ultrasound and/or CT scan, and bone scan. 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 treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating center which can be the Principal or the Co- Investigator's site.
Who cannot join
- Early breast cancer with a tumor size of < 2 cm measured by palpation.
- Patients with low or moderate risk. These patients are defined as having none of the following risk factors: Age < 36 years, cT> 5cm, ER and PR negative, cN+, or Grade III.
- Evidence of distant metastasis.
- Prior chemotherapy for any malignancy.
- Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment.
- Pre-existing motor or sensory neuropathy of a severity > grade 2 by NCI criteria.
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- Other serious illness or medical condition:
- previous malignant disease with a disease-free survival of less than 5 years (except CIS of the Cervix and non-melanomatous skin cancer.
- congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year prior to study entry, uncontrolled arterial hypertension or high-risk uncontrolled arrhythmias.
- history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.
- active uncontrolled infection.
- active peptic ulcer, unstable diabetes mellitus.
- Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (</= 20 mg methylprednisolone or equivalent).
- Concurrent treatment with sex hormones. Prior treatment must be stopped before study entry.
- Definite contraindications for the use of corticosteroids.
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
- Concurrent treatment with any other anti-cancer therapy.
- Known hypersensitivity reaction to one of the investigational compounds or incorporated substances.
- Male patients.
About this study
Official title: A Multi-center Randomized Phase III Study Evaluating 4 Cycles of Docetaxel, Doxorubicin and Cyclophosphamide Versus 4 Cycles of Vinorelbine and Capecitabine in Patients Not Sufficiently Responding to 2 Cycles of TAC and 4 Cycles of TAC Versus 6 Cycles of TAC in Patients Sufficiently Responding to 2 Cycles of TAC as Preoperative Treatment of Locally Advanced or Operable Primary Breast Cancer
Primary objective of the study in patients without a sufficient sonographic response (i.e. iNC) to 2 cycles of TAC as preoperative treatment of operable (T>/= 2cm, N0-2,M0) primary breast cancer: To determine the response rate determined by sonography (iRR = iCR+iPR) of further 4 cycles of docetaxel, doxorubicin and cyclophosphamide (TAC) and of 4 cycles of vinorelbine and capecitabine (NX) (TAC vs. NX)
Primary objective of the study in patients with a sufficient sonographic response (i.e. iRR = iPR or iCR) to the first 2 cycles of TAC as preoperative treatment of operable (T>/=2cm, N0-2,M0) primary breast cancer: To determine the pCR rate of 6 cycles vs. 8 cycles of docetaxel, doxorubicin and cyclophosphamide (TAC x 6 vs. TAC x 8)
Read the detailed description
Prospective, randomized phase III trial Study population I: operable (T>/=2cm, N0-2,M0) primary breast cancer Study population II: locally advanced (T4 a-d, N0-3,M0) primary breast cancer patients
All patients will receive 2 cycles of TAC. Thereafter
- Patients sufficiently responding (iPR, iCR) will be randomized to either 4 further cycles of TAC or 6 further cycles of TAC
- Patients non-sufficiently responding (iNC) will be randomized to either 4 further cycles of TAC or 4 cycles of NX:
TAC: Docetaxel 75 mg/m² as a 1 hour i.v. infusion on day 1 every 3 weeks in combination with Doxorubicin 50 mg/m² as an i.v. bolus and Cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks
NX: Vinorelbine 25 mg/m² as a 10 min i.v. infusion on days 1 and 8 repeated every 3 weeks and Capecitabine 2000 mg/m² orally in 2 daily doses on days 1-14 repeated every 3 weeks If a patient shows progressive disease during the first 2 cycles of TAC she will not be randomized and will be treated according to the discretion of the investigator. In patients with disease progression during further preoperative therapy, the treatment should be discontinued and patients should be treated by immediate surgery. In case of inoperability even after termination of chemotherapy further treatment is to the discretion of the investigator (e.g. radiotherapy).
Dose reduction and/or treatment delay and treatment discontinuation are planned in case of severe hematological and/or non-hematological toxicities.
After completion of chemotherapy and assessment of response, all patients should undergo surgery. Surgery should be performed 1-14 days after completion (i.e. day 21) of the last chemotherapy cycle. If the tumor is still too large for breast conservation, modified radical mastectomy is recommended. The patient can be offered autologous or heterologous reconstructive surgery. Sentinel node biopsy is allowed to be the only dissected axillary lymph node in patients with a pathological complete response and non involved sentinel node. Surgical reports will be collected and analyzed centrally.
The excised breast tissue should be examined by the pathologist according to guidelines given in the appendix. Histology reports will be collected and analyzed centrally.
Radiotherapy should be applied according to guidelines. Further postoperative systemic treatment is not planned except tamoxifen 20 mg p.o. daily for 5 years (starting after surgery) to patients with positive estrogen and/or progesterone receptors unless there is a contraindication for the use of tamoxifen therapy.
- Conditions
- Breast Cancer
- Being tested
- TAC, NX
- Keywords
- Breast cancer, neoadjuvant therapy, pCR rates
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACDrug
Docetaxel 75 mg/m² as a 1 hour i.v. infusion on day 1 every 3 weeks in combination with Doxorubicin 50 mg/m² as an i.v. bolus and Cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks
NXDrug
Vinorelbine 25 mg/m² as a < 10 min i.v. infusion on days 1 and 8 repeated every 3 weeks and Capecitabine 2000 mg/m² orally in 2 daily doses on days 1-14 repeated every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| resp: 4xTAC | Experimental | Patients sufficiently responding (iPR, iCR) will recieve 4 further cycles of TAC Receives: Drug: TAC |
| resp: 6xTAC | Experimental | Patients sufficiently responding (iPR, iCR) will recieve 6 further cycles of TAC Receives: Drug: TAC |
| nonResp: 4xTAC | Experimental | Patients non-sufficiently responding (iNC) will recieve 4 further cycles of TAC Receives: Drug: TAC |
| nonResp: 4xNX | Experimental | Patients non-sufficiently responding (iNC) will recieve 4 further cycles of NX Receives: Drug: NX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of pCR rates
To determine the iRR rate of 4 cycles of docetaxel, doxorubicin and cyclophosphamide (TAC) and of 4 cycles of vinorelbine and capecitabine (NX) (TAC-NX) as a salvage treatment
Measured: 2010
Secondary outcomes (4)
To determine the toxicity and compliance to each arm
Any grade III/IV toxicity (NCI-CTC Version 2.0) Premature treatment discontinuation
Measured: 2010
To determine the breast conservation rate in each arm
Any breast conservation without reconstruction
Measured: 2010
To determine the disease-free and overall survival in each arm
Any disease related event (recurrence, metastasis) and/or death after primary diagnosis
Measured: 2010
To determine the specificity and sensitivity of a presurgical core biopsy to predict the degree of pathologic tumor regression
No microscopic evidence of residual viable tumor cells (invasive or non-invasive) in all resected specimens of the breast
Measured: 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startSep 2002
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,014 participants (actual)
Sponsor and investigators
- Lead sponsor
- GBG Forschungs GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunter von Minckwitz, MD, Principal investigator, GBG Forschungs GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544765
- Sponsor's protocol ID
- GBG 24
- Acronym
- GeparTrio
- Status last verified
- Feb 2021
- First submitted
- 20 Jul 2007
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
von Minckwitz G, Kummel S, Vogel P, Hanusch C, Eidtmann H, Hilfrich J, Gerber B, Huober J, Costa SD, Jackisch C, Loibl S, Mehta K, Kaufmann M; German Breast Group. Neoadjuvant vinorelbine-capecitabine versus docetaxel-doxorubicin-cyclophosphamide in early nonresponsive breast cancer: phase III randomized GeparTrio trial. J Natl Cancer Inst. 2008 Apr 16;100(8):542-51. doi: 10.1093/jnci/djn085. Epub 2008 Apr 8.
PubMed 18398097Costa SD, Loibl S, Kaufmann M, Zahm DM, Hilfrich J, Huober J, Eidtmann H, du Bois A, Blohmer JU, Ataseven B, Weiss E, Tesch H, Gerber B, Baumann KH, Thomssen C, Breitbach GP, Ibishi S, Jackisch C, Mehta K, von Minckwitz G. Neoadjuvant chemotherapy shows similar response in patients with inflammatory or locally advanced breast cancer when compared with operable breast cancer: a secondary analysis of the GeparTrio trial data. J Clin Oncol. 2010 Jan 1;28(1):83-91. doi: 10.1200/JCO.2009.23.5101. Epub 2009 Nov 9.
PubMed 19901111Rody A, Karn T, Gatje R, Ahr A, Solbach C, Kourtis K, Munnes M, Loibl S, Kissler S, Ruckhaberle E, Holtrich U, von Minckwitz G, Kaufmann M. Gene expression profiling of breast cancer patients treated with docetaxel, doxorubicin, and cyclophosphamide within the GEPARTRIO trial: HER-2, but not topoisomerase II alpha and microtubule-associated protein tau, is highly predictive of tumor response. Breast. 2007 Feb;16(1):86-93. doi: 10.1016/j.breast.2006.06.008. Epub 2006 Sep 28.
PubMed 17010609Leichsenring J, Vladimirova V, Solbach C, Karn T, Ataseven B, Sinn BV, Barinoff J, Muller V, Blohmer JU, Schem C, Engels K, Marme F, Fisseler-Eckhoff A, Fasching PA, Stickeler E, van Mackelenbergh M, Denkert C, Stenzinger A, Loibl S, Groschel S. EVI1 expression in early-stage breast cancer patients treated with neoadjuvant chemotherapy. BMC Cancer. 2022 Oct 5;22(1):1040. doi: 10.1186/s12885-022-10109-1.
PubMed 36195836Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
PubMed 34037241Lindner JL, Loibl S, Denkert C, Ataseven B, Fasching PA, Pfitzner BM, Gerber B, Gade S, Darb-Esfahani S, Sinn BV, Huober J, Engels K, Tesch H, Karn T, Pommerenke F, Liedtke C, Untch M, Muller V, Rack B, Schem C, von Minckwitz G. Expression of secreted protein acidic and rich in cysteine (SPARC) in breast cancer and response to neoadjuvant chemotherapy. Ann Oncol. 2015 Jan;26(1):95-100. doi: 10.1093/annonc/mdu487. Epub 2014 Oct 29.
PubMed 25355716Darb-Esfahani S, von Minckwitz G, Denkert C, Ataseven B, Hogel B, Mehta K, Kaltenecker G, Rudiger T, Pfitzner B, Kittel K, Fiedler B, Baumann K, Moll R, Dietel M, Eidtmann H, Thomssen C, Loibl S. Gross cystic disease fluid protein 15 (GCDFP-15) expression in breast cancer subtypes. BMC Cancer. 2014 Jul 28;14:546. doi: 10.1186/1471-2407-14-546.
PubMed 25070172von Minckwitz G, Blohmer JU, Costa SD, Denkert C, Eidtmann H, Eiermann W, Gerber B, Hanusch C, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Kummel S, Paepke S, Schneeweiss A, Untch M, Zahm DM, Mehta K, Loibl S. Response-guided neoadjuvant chemotherapy for breast cancer. J Clin Oncol. 2013 Oct 10;31(29):3623-30. doi: 10.1200/JCO.2012.45.0940. Epub 2013 Sep 3.
PubMed 24002511Sinn BV, von Minckwitz G, Denkert C, Eidtmann H, Darb-Esfahani S, Tesch H, Kronenwett R, Hoffmann G, Belau A, Thommsen C, Holzhausen HJ, Grasshoff ST, Baumann K, Mehta K, Dietel M, Loibl S. Evaluation of Mucin-1 protein and mRNA expression as prognostic and predictive markers after neoadjuvant chemotherapy for breast cancer. Ann Oncol. 2013 Sep;24(9):2316-24. doi: 10.1093/annonc/mdt162. Epub 2013 May 9.
PubMed 23661292von Minckwitz G, Untch M, Blohmer JU, Costa SD, Eidtmann H, Fasching PA, Gerber B, Eiermann W, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Konecny GE, Denkert C, Nekljudova V, Mehta K, Loibl S. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol. 2012 May 20;30(15):1796-804. doi: 10.1200/JCO.2011.38.8595. Epub 2012 Apr 16.
PubMed 22508812
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Randomized Phase III Study Evaluating 4 Cycles of Docetaxel, Doxorubicin and Cyclophosphamide Versus 4 Cycles of Vinorelbine and Capecitabine in Patients Not Sufficiently Responding to 2 Cycles of TAC and 4 Cycles of TAC Versus 6 Cycles of TAC in Patients Sufficiently Responding to 2 Cycles of TAC as Preoperative Treatment of Locally Advanced or Operable Primary Breast Cancer
- ClinicalTrials.gov ID
- NCT00544765
- Acronym / sponsor ID
- GeparTrio / GBG 24
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, neoadjuvant therapy, pCR rates
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,014 participants (actual)
- Lead sponsor
- GBG Forschungs GmbHUniversity, hospital or other
- Collaborators
- Roche Pharma AG, Sanofi, Amgen, Goethe University
- Study start
- Sep 2002
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 16 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective of the study in patients without a sufficient sonographic response (i.e. iNC) to 2 cycles of TAC as preoperative treatment of operable (T>/= 2cm, N0-2,M0) primary breast cancer: To determine the response rate determined by sonography (iRR = iCR+iPR) of further 4 cycles of docetaxel, doxorubicin and cyclophosphamide (TAC) and of 4 cycles of vinorelbine and capecitabine (NX) (TAC vs. NX)
Primary objective of the study in patients with a sufficient sonographic response (i.e. iRR = iPR or iCR) to the first 2 cycles of TAC as preoperative treatment of operable (T>/=2cm, N0-2,M0) primary breast cancer: To determine the pCR rate of 6 cycles vs. 8 cycles of docetaxel, doxorubicin and cyclophosphamide (TAC x 6 vs. TAC x 8)
Detailed description
Prospective, randomized phase III trial Study population I: operable (T>/=2cm, N0-2,M0) primary breast cancer Study population II: locally advanced (T4 a-d, N0-3,M0) primary breast cancer patients
All patients will receive 2 cycles of TAC. Thereafter
- Patients sufficiently responding (iPR, iCR) will be randomized to either 4 further cycles of TAC or 6 further cycles of TAC
- Patients non-sufficiently responding (iNC) will be randomized to either 4 further cycles of TAC or 4 cycles of NX:
TAC: Docetaxel 75 mg/m² as a 1 hour i.v. infusion on day 1 every 3 weeks in combination with Doxorubicin 50 mg/m² as an i.v. bolus and Cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks
NX: Vinorelbine 25 mg/m² as a 10 min i.v. infusion on days 1 and 8 repeated every 3 weeks and Capecitabine 2000 mg/m² orally in 2 daily doses on days 1-14 repeated every 3 weeks If a patient shows progressive disease during the first 2 cycles of TAC she will not be randomized and will be treated according to the discretion of the investigator. In patients with disease progression during further preoperative therapy, the treatment should be discontinued and patients should be treated by immediate surgery. In case of inoperability even after termination of chemotherapy further treatment is to the discretion of the investigator (e.g. radiotherapy).
Dose reduction and/or treatment delay and treatment discontinuation are planned in case of severe hematological and/or non-hematological toxicities.
After completion of chemotherapy and assessment of response, all patients should undergo surgery. Surgery should be performed 1-14 days after completion (i.e. day 21) of the last chemotherapy cycle. If the tumor is still too large for breast conservation, modified radical mastectomy is recommended. The patient can be offered autologous or heterologous reconstructive surgery. Sentinel node biopsy is allowed to be the only dissected axillary lymph node in patients with a pathological complete response and non involved sentinel node. Surgical reports will be collected and analyzed centrally.
The excised breast tissue should be examined by the pathologist according to guidelines given in the appendix. Histology reports will be collected and analyzed centrally.
Radiotherapy should be applied according to guidelines. Further postoperative systemic treatment is not planned except tamoxifen 20 mg p.o. daily for 5 years (starting after surgery) to patients with positive estrogen and/or progesterone receptors unless there is a contraindication for the use of tamoxifen therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| resp: 4xTAC | Experimental | Drug: TACPatients sufficiently responding (iPR, iCR) will recieve 4 further cycles of TAC |
| resp: 6xTAC | Experimental | Drug: TACPatients sufficiently responding (iPR, iCR) will recieve 6 further cycles of TAC |
| nonResp: 4xTAC | Experimental | Drug: TACPatients non-sufficiently responding (iNC) will recieve 4 further cycles of TAC |
| nonResp: 4xNX | Experimental | Drug: NXPatients non-sufficiently responding (iNC) will recieve 4 further cycles of NX |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
- Complete baseline documentation sent to SKM CRS.
- Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration 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 in maximum diameter. The leasion has to be measurable in two-dimensions by sonography. In case of inflammatory disease the extent of inflammation can be used as measurable lesion. The following tumor stages are eligible:
- Age > 18 years.
Key exclusion criteria (19 listed)
- Early breast cancer with a tumor size of < 2 cm measured by palpation.
- Patients with low or moderate risk. These patients are defined as having none of the following risk factors: Age < 36 years, cT> 5cm, ER and PR negative, cN+, or Grade III.
- Evidence of distant metastasis.
- Prior chemotherapy for any malignancy.
- Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TACDocetaxel 75 mg/m² as a 1 hour i.v. infusion on day 1 every 3 weeks in combination with Doxorubicin 50 mg/m² as an i.v. bolus and Cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks | Drug | nonResp: 4xTAC, resp: 4xTAC, resp: 6xTAC |
| NXVinorelbine 25 mg/m² as a < 10 min i.v. infusion on days 1 and 8 repeated every 3 weeks and Capecitabine 2000 mg/m² orally in 2 daily doses on days 1-14 repeated every 3 weeks | Drug | nonResp: 4xNX |
Primary outcome
Determination of pCR rates
Time frame: 2010
To determine the iRR rate of 4 cycles of docetaxel, doxorubicin and cyclophosphamide (TAC) and of 4 cycles of vinorelbine and capecitabine (NX) (TAC-NX) as a salvage treatment
4 secondary outcomes
To determine the toxicity and compliance to each arm
Time frame: 2010
To determine the breast conservation rate in each arm
Time frame: 2010
To determine the disease-free and overall survival in each arm
Time frame: 2010
To determine the specificity and sensitivity of a presurgical core biopsy to predict the degree of pathologic tumor regression
Time frame: 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Results publication: PubMed 18398097von Minckwitz G, Kummel S, Vogel P, Hanusch C, Eidtmann H, Hilfrich J, Gerber B, Huober J, Costa SD, Jackisch C, Loibl S, Mehta K, Kaufmann M; German Breast Group. Neoadjuvant vinorelbine-capecitabine versus docetaxel-doxorubicin-cyclophosphamide in early nonresponsive breast cancer: phase III randomized GeparTrio trial. J Natl Cancer Inst. 2008 Apr 16;100(8):542-51. doi: 10.1093/jnci/djn085. Epub 2008 Apr 8.
- Results publication: PubMed 19901111Costa SD, Loibl S, Kaufmann M, Zahm DM, Hilfrich J, Huober J, Eidtmann H, du Bois A, Blohmer JU, Ataseven B, Weiss E, Tesch H, Gerber B, Baumann KH, Thomssen C, Breitbach GP, Ibishi S, Jackisch C, Mehta K, von Minckwitz G. Neoadjuvant chemotherapy shows similar response in patients with inflammatory or locally advanced breast cancer when compared with operable breast cancer: a secondary analysis of the GeparTrio trial data. J Clin Oncol. 2010 Jan 1;28(1):83-91. doi: 10.1200/JCO.2009.23.5101. Epub 2009 Nov 9.
- Results publication: PubMed 17010609Rody A, Karn T, Gatje R, Ahr A, Solbach C, Kourtis K, Munnes M, Loibl S, Kissler S, Ruckhaberle E, Holtrich U, von Minckwitz G, Kaufmann M. Gene expression profiling of breast cancer patients treated with docetaxel, doxorubicin, and cyclophosphamide within the GEPARTRIO trial: HER-2, but not topoisomerase II alpha and microtubule-associated protein tau, is highly predictive of tumor response. Breast. 2007 Feb;16(1):86-93. doi: 10.1016/j.breast.2006.06.008. Epub 2006 Sep 28.
- Derived from this study: PubMed 36195836Leichsenring J, Vladimirova V, Solbach C, Karn T, Ataseven B, Sinn BV, Barinoff J, Muller V, Blohmer JU, Schem C, Engels K, Marme F, Fisseler-Eckhoff A, Fasching PA, Stickeler E, van Mackelenbergh M, Denkert C, Stenzinger A, Loibl S, Groschel S. EVI1 expression in early-stage breast cancer patients treated with neoadjuvant chemotherapy. BMC Cancer. 2022 Oct 5;22(1):1040. doi: 10.1186/s12885-022-10109-1.
- Derived from this study: PubMed 34037241Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
- Derived from this study: PubMed 25355716Lindner JL, Loibl S, Denkert C, Ataseven B, Fasching PA, Pfitzner BM, Gerber B, Gade S, Darb-Esfahani S, Sinn BV, Huober J, Engels K, Tesch H, Karn T, Pommerenke F, Liedtke C, Untch M, Muller V, Rack B, Schem C, von Minckwitz G. Expression of secreted protein acidic and rich in cysteine (SPARC) in breast cancer and response to neoadjuvant chemotherapy. Ann Oncol. 2015 Jan;26(1):95-100. doi: 10.1093/annonc/mdu487. Epub 2014 Oct 29.
- Derived from this study: PubMed 25070172Darb-Esfahani S, von Minckwitz G, Denkert C, Ataseven B, Hogel B, Mehta K, Kaltenecker G, Rudiger T, Pfitzner B, Kittel K, Fiedler B, Baumann K, Moll R, Dietel M, Eidtmann H, Thomssen C, Loibl S. Gross cystic disease fluid protein 15 (GCDFP-15) expression in breast cancer subtypes. BMC Cancer. 2014 Jul 28;14:546. doi: 10.1186/1471-2407-14-546.
- Derived from this study: PubMed 24002511von Minckwitz G, Blohmer JU, Costa SD, Denkert C, Eidtmann H, Eiermann W, Gerber B, Hanusch C, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Kummel S, Paepke S, Schneeweiss A, Untch M, Zahm DM, Mehta K, Loibl S. Response-guided neoadjuvant chemotherapy for breast cancer. J Clin Oncol. 2013 Oct 10;31(29):3623-30. doi: 10.1200/JCO.2012.45.0940. Epub 2013 Sep 3.
- Derived from this study: PubMed 23661292Sinn BV, von Minckwitz G, Denkert C, Eidtmann H, Darb-Esfahani S, Tesch H, Kronenwett R, Hoffmann G, Belau A, Thommsen C, Holzhausen HJ, Grasshoff ST, Baumann K, Mehta K, Dietel M, Loibl S. Evaluation of Mucin-1 protein and mRNA expression as prognostic and predictive markers after neoadjuvant chemotherapy for breast cancer. Ann Oncol. 2013 Sep;24(9):2316-24. doi: 10.1093/annonc/mdt162. Epub 2013 May 9.
- Derived from this study: PubMed 22508812von Minckwitz G, Untch M, Blohmer JU, Costa SD, Eidtmann H, Fasching PA, Gerber B, Eiermann W, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Konecny GE, Denkert C, Nekljudova V, Mehta K, Loibl S. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol. 2012 May 20;30(15):1796-804. doi: 10.1200/JCO.2011.38.8595. Epub 2012 Apr 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunter von Minckwitz, MD principal investigator
GBG Forschungs GmbH
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TAC and NX in people with Breast Cancer, run by GBG Forschungs GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of pCR rates (time frame: 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00544765, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.