Breast CancerNCT04829890
Adjuvant Chemotherapy With Epirubicin, CMF, and Weekly Docetaxel or Weekly Paclitaxel in Patients With Resected High-risk Breast Cancer
An observational study of Breast Cancer and Adenocarcinoma of Breast, run by Hellenic Cooperative Oncology Group.
Trial summary
This study was a transnational pooled analysis of biological material from patients with resected high risk breast cancer who had received adjuvant chemotherapy with epirubicin and cyclophosphamide followed by weekly docetaxel or weekly paclitaxel. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Adenocarcinoma of Breast
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Nov 2014
- Phase
- Observational
- 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
Study population: This is a transnational pooled analysis, feasibility study from two sequential studies with biological material from patients with confirmed breast cancer with high risk of recurrence. Patients have been treated in Hellenic Cooperative Oncology Group (HeCOG) affiliated departments of oncology.
Who may be able to join
- Histology-confirmed epithelial cancer of the mammary gland.
- Pre and post menopausal patients with early breast cancer and involved axillary lymph nodes (T 1-3 N1 M0) or high-risk N0 patients. A N0 patient is considered "high-risk" if she fulfills at least one of the following criteria; T>= 2cm, Estrogen Receptor (ER)/Progesterone receptor (PgR) negative, HER-2 3+, infiltration of blood or lymphatic vessels or nerves, grade 3.
- White Blood Cell count (WBC) > 4 x 109 / l, platelets > 100 x 109 / l.
- Serum creatinine, Aspartate aminotransferase (AST/SGOT),Alanine aminotransferase (ALT/SGPT), gamma-glutamyltransferase, serum bilirubin 1.3 mg/ml inside the normal range of the participating hospital.
- Performance status (WHO) 0 or 1.
- Age >=18 years
- Previous surgical treatment: Either radical surgery or, for a partial mastectomy, a histologically confirmed safe margin of 2 cm or more and the results of the axillary node dissection available.
- No evidence of significant cardiac disease
Who cannot join
- History of myocardial infarction within the previous 12 months or heart failure (including cardiac insufficiency controlled by digitalis and diuretics) or arrhythmias requiring medication or uncontrolled arterial hypertension (BP> 200/110 mm Hg). A normal baseline Left Ventricular Ejection Fraction (LVEF) should be demonstrated by multigated acquisition (MUGA) scan or echocardiogram.
- No previous antitumor chemotherapy or radiation
- Time from surgery 2 to 4 weeks
About this study
Official title: Adjuvant Dose-dense Sequential Chemotherapy With Epirubicin, CMF, and Weekly Docetaxel or Weekly Paclitaxel in Patients With Resected High-risk Breast Cancer: A Hellenic Cooperative Oncology Group (HeCOG) Study
This study was a transnational pooled analysis of biological material from patients with resected high risk breast cancer who had received adjuvant chemotherapy with epirubicin and cyclophosphamide followed by weekly docetaxel or weekly paclitaxel.
Read the detailed description
This was a transnational analysis of biological material from patients with resected high risk breast cancer who are treated at Hellenic Cooperative Oncology Group (HeCOG) affiliated departments of oncology. This study was a pooled analysis of two separate sequential feasibility studies who received the below described treatment. Patients who participated were 18 years old or older, women of any menopausal status who received epirubicin for 3 cycles every 2 weeks followed by 3 cycles with cyclophosphamide every 2 weeks followed 3 weeks later by 9 weekly cycles with docetaxel or paclitaxel. G-CSF was given on days 2-7 of each cycle during treatment with Epirubicin and cyclophosphamide. All premenopausal patients with receptor positive status received tamoxifen 20 mg p.o. daily for 5 years. All postmenopausal patients with receptor positive status were treated with anastrazole 1mg for 5 years. RT was required for all patients (pre- or post -menopausal), providing that they had either a partial mastectomy or tumor size > 5cm and /or more than 4 positive lymph nodes, irrespectively the type of surgery (conservative or radical).
- Conditions
- Breast Cancer, Adenocarcinoma of Breast
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the feasibility profile of dose dense sequential chemotherapy with Epirubicin, cyclophosphamide and weekly docetaxel or weekly paclitaxel.
Measured: Up to 147 days
Number of Participants with Treatment-Related Adverse Events treated with dose dense sequential chemotherapy with Epirubicin, cyclophosphamide and weekly docetaxel or weekly paclitaxel.
Measured: Up to 147 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study startFeb 2004
- Primary completionApr 2006
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829890
- Sponsor's protocol ID
- HE10/04
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. doi: 10.1016/S0140-6736(05)66544-0.
PubMed 15894097Norton L. Theoretical concepts and the emerging role of taxanes in adjuvant therapy. Oncologist. 2001;6 Suppl 3:30-5. doi: 10.1634/theoncologist.6-suppl_3-30.
PubMed 11346683Citron ML. Dose density in adjuvant chemotherapy for breast cancer. Cancer Invest. 2004;22(4):555-68. doi: 10.1081/cnv-200027134.
PubMed 15565814Colozza M, de Azambuja E, Cardoso F, Bernard C, Piccart MJ. Breast cancer: achievements in adjuvant systemic therapies in the pre-genomic era. Oncologist. 2006 Feb;11(2):111-25. doi: 10.1634/theoncologist.11-2-111.
PubMed 16476832Henderson IC, Berry DA, Demetri GD, Cirrincione CT, Goldstein LJ, Martino S, Ingle JN, Cooper MR, Hayes DF, Tkaczuk KH, Fleming G, Holland JF, Duggan DB, Carpenter JT, Frei E 3rd, Schilsky RL, Wood WC, Muss HB, Norton L. Improved outcomes from adding sequential Paclitaxel but not from escalating Doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol. 2003 Mar 15;21(6):976-83. doi: 10.1200/JCO.2003.02.063.
PubMed 12637460Hudis, C.; Citron, M.; Berry, D.; Cirrincione, C.; Gradishar, W.; Davidson, N.; Martino, S.; Livingston, R.; Ingle, J.; Perez, E.; Abrams, J.; Schilsky, R.; Ellis, M.; Muss, H.; Norton, L.; Winer E. Five year follow-up of INT C9741: dose-dense (DD) chemotherapy (CRx) is safe and effective. San Antonio Breast Cancer Symposium 2005, Abstract 41
Mamounas EP, Bryant J, Lembersky B, Fehrenbacher L, Sedlacek SM, Fisher B, Wickerham DL, Yothers G, Soran A, Wolmark N. Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28. J Clin Oncol. 2005 Jun 1;23(16):3686-96. doi: 10.1200/JCO.2005.10.517. Epub 2005 May 16.
PubMed 15897552Crown, J.P.; Francis, P.; Di Leo, A.; Buyse, M.; Balil, A.; Anderson, M.; Nordenskj¨ old, B.; Jakesz, R.; Gutierrez J.; PiccartM. Docetaxel (T) given concurrently with or sequentially to anthracycline-based (A) adjuvant therapy (adjRx) for patients (pts) with node-positive (N+) breast cancer (BrCa), in comparison with non-T adjRx: First results of the BIG 2-98 Trial at 5 years median follow-up (MFU). J Clin Oncol, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: LBA519
Fountzilas G, Skarlos D, Dafni U, Gogas H, Briasoulis E, Pectasides D, Papadimitriou C, Markopoulos C, Polychronis A, Kalofonos HP, Siafaka V, Kosmidis P, Timotheadou E, Tsavdaridis D, Bafaloukos D, Papakostas P, Razis E, Makrantonakis P, Aravantinos G, Christodoulou C, Dimopoulos AM. Postoperative dose-dense sequential chemotherapy with epirubicin, followed by CMF with or without paclitaxel, in patients with high-risk operable breast cancer: a randomized phase III study conducted by the Hellenic Cooperative Oncology Group. Ann Oncol. 2005 Nov;16(11):1762-71. doi: 10.1093/annonc/mdi366. Epub 2005 Sep 7.
PubMed 16148021Eniu A, Palmieri FM, Perez EA. Weekly administration of docetaxel and paclitaxel in metastatic or advanced breast cancer. Oncologist. 2005 Oct;10(9):665-85. doi: 10.1634/theoncologist.10-9-665.
PubMed 16249346Seidman AD, Hudis CA, Albanell J, Tong W, Tepler I, Currie V, Moynahan ME, Theodoulou M, Gollub M, Baselga J, Norton L. Dose-dense therapy with weekly 1-hour paclitaxel infusions in the treatment of metastatic breast cancer. J Clin Oncol. 1998 Oct;16(10):3353-61. doi: 10.1200/JCO.1998.16.10.3353.
PubMed 9779712Wist EA, Sommer HH, Ostenstad B, Risberg T, Fjaestad K. Weekly one-hour paclitaxel as first-line chemotherapy for metastatic breast cancer. Acta Oncol. 2004;43(1):11-4. doi: 10.1080/02841860310017748.
PubMed 15068314Sato K, Inoue K, Saito T, Kai T, Mihara H, Okubo K, Koh J, Mochizuki H, Tabei T; Saitama Breast Cancer Clinical Study Group. Multicenter phase II trial of weekly paclitaxel for advanced or metastatic breast cancer: the Saitama Breast Cancer Clinical Study Group (SBCCSG-01). Jpn J Clin Oncol. 2003 Aug;33(8):371-6. doi: 10.1093/jjco/hyg075.
PubMed 14523055Gori S, Mosconi AM, Basurtol C, Cherubinil R, De Angelis V, Tonato M, Colozza M. Weekly paclitaxel in metastatic breast cancer patients: a phase II study. Tumori. 2002 Nov-Dec;88(6):470-3. doi: 10.1177/030089160208800607.
PubMed 12597140Perez EA, Vogel CL, Irwin DH, Kirshner JJ, Patel R. Multicenter phase II trial of weekly paclitaxel in women with metastatic breast cancer. J Clin Oncol. 2001 Nov 15;19(22):4216-23. doi: 10.1200/JCO.2001.19.22.4216.
PubMed 11709565
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Dose-dense Sequential Chemotherapy With Epirubicin, CMF, and Weekly Docetaxel or Weekly Paclitaxel in Patients With Resected High-risk Breast Cancer: A Hellenic Cooperative Oncology Group (HeCOG) Study
- ClinicalTrials.gov ID
- NCT04829890
- Acronym / sponsor ID
- HE10/04
- Conditions
- Breast Cancer, Adenocarcinoma of Breast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Hellenic Cooperative Oncology GroupUniversity, hospital or other
- Study start
- Feb 2004 (actual)
- Primary completion
- Apr 2006 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Apr 2021 (actual)
- 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.
This study was a transnational pooled analysis of biological material from patients with resected high risk breast cancer who had received adjuvant chemotherapy with epirubicin and cyclophosphamide followed by weekly docetaxel or weekly paclitaxel.
Detailed description
This was a transnational analysis of biological material from patients with resected high risk breast cancer who are treated at Hellenic Cooperative Oncology Group (HeCOG) affiliated departments of oncology. This study was a pooled analysis of two separate sequential feasibility studies who received the below described treatment. Patients who participated were 18 years old or older, women of any menopausal status who received epirubicin for 3 cycles every 2 weeks followed by 3 cycles with cyclophosphamide every 2 weeks followed 3 weeks later by 9 weekly cycles with docetaxel or paclitaxel. G-CSF was given on days 2-7 of each cycle during treatment with Epirubicin and cyclophosphamide. All premenopausal patients with receptor positive status received tamoxifen 20 mg p.o. daily for 5 years. All postmenopausal patients with receptor positive status were treated with anastrazole 1mg for 5 years. RT was required for all patients (pre- or post -menopausal), providing that they had either a partial mastectomy or tumor size > 5cm and /or more than 4 positive lymph nodes, irrespectively the type of surgery (conservative or radical).
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a transnational pooled analysis, feasibility study from two sequential studies with biological material from patients with confirmed breast cancer with high risk of recurrence. Patients have been treated in Hellenic Cooperative Oncology Group (HeCOG) affiliated departments of oncology.
Key inclusion criteria (8 listed)
- Histology-confirmed epithelial cancer of the mammary gland.
- Pre and post menopausal patients with early breast cancer and involved axillary lymph nodes (T 1-3 N1 M0) or high-risk N0 patients. A N0 patient is considered "high-risk" if she fulfills at least one of the following criteria; T>= 2cm, Estrogen Receptor (ER)/Progesterone receptor (PgR) negative, HER-2 3+, infiltration of blood or lymphatic vessels or nerves, grade 3.
- White Blood Cell count (WBC) > 4 x 109 / l, platelets > 100 x 109 / l.
- Serum creatinine, Aspartate aminotransferase (AST/SGOT),Alanine aminotransferase (ALT/SGPT), gamma-glutamyltransferase, serum bilirubin 1.3 mg/ml inside the normal range of the participating hospital.
- Performance status (WHO) 0 or 1.
Key exclusion criteria (3 listed)
- History of myocardial infarction within the previous 12 months or heart failure (including cardiac insufficiency controlled by digitalis and diuretics) or arrhythmias requiring medication or uncontrolled arterial hypertension (BP> 200/110 mm Hg). A normal baseline Left Ventricular Ejection Fraction (LVEF) should be demonstrated by multigated acquisition (MUGA) scan or echocardiogram.
- No previous antitumor chemotherapy or radiation
- Time from surgery 2 to 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluating the feasibility profile of dose dense sequential chemotherapy with Epirubicin, cyclophosphamide and weekly docetaxel or weekly paclitaxel.
Time frame: Up to 147 days
Number of Participants with Treatment-Related Adverse Events treated with dose dense sequential chemotherapy with Epirubicin, cyclophosphamide and weekly docetaxel or weekly paclitaxel.
Time frame: Up to 147 days
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 6 Apr 2021.
- Background: PubMed 15894097Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. doi: 10.1016/S0140-6736(05)66544-0.
- Background: PubMed 11346683Norton L. Theoretical concepts and the emerging role of taxanes in adjuvant therapy. Oncologist. 2001;6 Suppl 3:30-5. doi: 10.1634/theoncologist.6-suppl_3-30.
- Background: PubMed 15565814Citron ML. Dose density in adjuvant chemotherapy for breast cancer. Cancer Invest. 2004;22(4):555-68. doi: 10.1081/cnv-200027134.
- Background: PubMed 16476832Colozza M, de Azambuja E, Cardoso F, Bernard C, Piccart MJ. Breast cancer: achievements in adjuvant systemic therapies in the pre-genomic era. Oncologist. 2006 Feb;11(2):111-25. doi: 10.1634/theoncologist.11-2-111.
- Background: PubMed 12637460Henderson IC, Berry DA, Demetri GD, Cirrincione CT, Goldstein LJ, Martino S, Ingle JN, Cooper MR, Hayes DF, Tkaczuk KH, Fleming G, Holland JF, Duggan DB, Carpenter JT, Frei E 3rd, Schilsky RL, Wood WC, Muss HB, Norton L. Improved outcomes from adding sequential Paclitaxel but not from escalating Doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol. 2003 Mar 15;21(6):976-83. doi: 10.1200/JCO.2003.02.063.
- BackgroundHudis, C.; Citron, M.; Berry, D.; Cirrincione, C.; Gradishar, W.; Davidson, N.; Martino, S.; Livingston, R.; Ingle, J.; Perez, E.; Abrams, J.; Schilsky, R.; Ellis, M.; Muss, H.; Norton, L.; Winer E. Five year follow-up of INT C9741: dose-dense (DD) chemotherapy (CRx) is safe and effective. San Antonio Breast Cancer Symposium 2005, Abstract 41
- Background: PubMed 15897552Mamounas EP, Bryant J, Lembersky B, Fehrenbacher L, Sedlacek SM, Fisher B, Wickerham DL, Yothers G, Soran A, Wolmark N. Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28. J Clin Oncol. 2005 Jun 1;23(16):3686-96. doi: 10.1200/JCO.2005.10.517. Epub 2005 May 16.
- BackgroundCrown, J.P.; Francis, P.; Di Leo, A.; Buyse, M.; Balil, A.; Anderson, M.; Nordenskj¨ old, B.; Jakesz, R.; Gutierrez J.; PiccartM. Docetaxel (T) given concurrently with or sequentially to anthracycline-based (A) adjuvant therapy (adjRx) for patients (pts) with node-positive (N+) breast cancer (BrCa), in comparison with non-T adjRx: First results of the BIG 2-98 Trial at 5 years median follow-up (MFU). J Clin Oncol, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: LBA519
- Background: PubMed 16148021Fountzilas G, Skarlos D, Dafni U, Gogas H, Briasoulis E, Pectasides D, Papadimitriou C, Markopoulos C, Polychronis A, Kalofonos HP, Siafaka V, Kosmidis P, Timotheadou E, Tsavdaridis D, Bafaloukos D, Papakostas P, Razis E, Makrantonakis P, Aravantinos G, Christodoulou C, Dimopoulos AM. Postoperative dose-dense sequential chemotherapy with epirubicin, followed by CMF with or without paclitaxel, in patients with high-risk operable breast cancer: a randomized phase III study conducted by the Hellenic Cooperative Oncology Group. Ann Oncol. 2005 Nov;16(11):1762-71. doi: 10.1093/annonc/mdi366. Epub 2005 Sep 7.
- Background: PubMed 16249346Eniu A, Palmieri FM, Perez EA. Weekly administration of docetaxel and paclitaxel in metastatic or advanced breast cancer. Oncologist. 2005 Oct;10(9):665-85. doi: 10.1634/theoncologist.10-9-665.
- Background: PubMed 9779712Seidman AD, Hudis CA, Albanell J, Tong W, Tepler I, Currie V, Moynahan ME, Theodoulou M, Gollub M, Baselga J, Norton L. Dose-dense therapy with weekly 1-hour paclitaxel infusions in the treatment of metastatic breast cancer. J Clin Oncol. 1998 Oct;16(10):3353-61. doi: 10.1200/JCO.1998.16.10.3353.
- Background: PubMed 15068314Wist EA, Sommer HH, Ostenstad B, Risberg T, Fjaestad K. Weekly one-hour paclitaxel as first-line chemotherapy for metastatic breast cancer. Acta Oncol. 2004;43(1):11-4. doi: 10.1080/02841860310017748.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Adenocarcinoma of Breast, run by Hellenic Cooperative Oncology Group.
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 8 inclusion and 3 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 6 Apr 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.
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?
Evaluating the feasibility profile of dose dense sequential chemotherapy with Epirubicin, cyclophosphamide and weekly docetaxel or weekly paclitaxel. (time frame: Up to 147 days). The study lists 2 primary outcomes in all. 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 NCT04829890, which also lists 47 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 6 Apr 2021.