Primary Breast CancerPhase 3NCT00793377
Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Docetaxel (AC-Doc) Versus Dose-Dense Doxorubicin and Docetaxel (ADoc) in Breast Cancer
A Phase 3 study testing Adriamycin (Doxorubicin), Docetaxel, Tamoxifen and Adriamycin (Doxorubicin), Docetaxel, Tamoxifen, Cyclophosphamid in people with Primary Breast Cancer, run by GBG Forschungs GmbH at 1 site in Germany.
Trial summary
The primary objective of this trial is to compare the rate of pathologically complete remissions achieved using a preoperative dose-intensified 8 week therapy consisting of adriamycin and docetaxel with a preoperative sequential 24 week regimen consisting of adriamycin/cyclophosphamide followed by docetaxel, in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Breast Cancer
- What is being tested?
- Adriamycin (Doxorubicin), Docetaxel, Tamoxifen and Adriamycin (Doxorubicin), Docetaxel, Tamoxifen, Cyclophosphamid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 913 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento Sep 2001
- 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
- Pre-study screening performed according to section 7.1
- Unilateral primary carcinoma of the breast, confirmed histologically by core or tru-cut biopsy. Fine-needle aspiration is not sufficient. Incisional biopsy is only allowed if less than 20% of the tumor is excised.
- Two-dimensionally measurable (mammography, ultrasound, or MRI) breast tumor
- Primary tumor >= 2 cm in largest diameter by either palpation, sonography or mammography, or breast MRI. In patients with multifocal or multicentric breast cancer, the largest lesion should be measured.
- No evidence of distant metastases
- Life expectancy of at least 10 years, disregarding the diagnosis of cancer.
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- Karnofsky index >= 70%.
- Age 18 years or older.
- Adequate hematological, renal, and hepatic function (WBC > 4000, platelets > 100 000, bilirubin, serum creatinine and transaminases within 1.5 × upper normal range).
- Evidence of normal cardiac function (with or without medication) from the patient history and from electrocardiography. Normal function is confirmed by echocardiography or multiple gated acquisition (MUGA) scan.
- Negative pregnancy test and appropriate nonhormonal contraception in fertile women. Intrauterine pessaries with progestogens are allowed.
- Written informed consent and assumed compliance for therapy and follow up of the patients.
- Consent of patient, pathologist and investigator to supply tumor material of biopsy and surgery for central pathologic evaluation and examination of predictive factors.
Who cannot join
- Locally advanced (stage T4), bilateral, metastatic, or inflammatory breast cancer. If one of these conditions is suspected, it has to be excluded before enrollment into study.
- Previous treatment for breast cancer, including surgery, radiation, cytotoxic, or endocrine treatments.
- Previous malignancy other than breast cancer or noninvasive breast cancer if the disease-free interval is less than 10 years.
- Previous cytotoxic treatment for any condition.
- Preexisting neurotoxicity greater than grade II.
- Active infection or other significant illness that could influence the tolerability of treatment.
- Current treatment with sex hormones (treatment has to be discontinued before the start of systemic therapy).
- Psychiatric illness or drug addiction that would preclude obtaining informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multicenter, Open Phase III Study Comparing a Dose-Intensified 8 Week Schedule of Adriamycin and Docetaxel (ADOC) With a Sequential 24 Week Schedule of Adriamycin/Cyclophosphamide Followed by Docetaxel (AC-DOC) Regimen as Preoperative Therapy in Patients With Operable Carcinoma of the Breast (T2-3 N0-2 M0)
The primary objective of this trial is to compare the rate of pathologically complete remissions achieved using a preoperative dose-intensified 8 week therapy consisting of adriamycin and docetaxel with a preoperative sequential 24 week regimen consisting of adriamycin/cyclophosphamide followed by docetaxel, in patients with operable carcinoma of the breast. Secondary aims are to assess disease-free and overall survival, the rate of complete and partial responses by palpation and imaging methods, the rate of breast-conserving operations, and the toxicity of the two chemotherapy regimens.
Women meeting the following criteria will be eligible for the study: those with operable breast cancer (T2-3 N0-2 M0), with the diagnosis histologically confirmed by biopsy, and measurable disease on mammography or sonography or breast MRI (the most appropriate method should be chosen by the investigator). After the patients have given written informed consent, they will be randomly assigned to the study treatments. Patients in group I will receive four cycles of combination chemotherapy consisting of adriamycin 50 mg/m2 (15 min i.v. infusion) and docetaxel 75 mg/m2 (1 h i.v. infusion) repeated every 14 days, followed by surgery 9-10 weeks after the start of therapy. Patients in group II will receive four cycles of adriamycin 60 mg/m2 (15 min i.v.) and cyclophosphamide 600 mg/m2 (1 h i.v.) every three weeks, followed by four cycles of docetaxel 100 mg/m2 (1 h i.v.) every three weeks. Surgery will be performed during week 25 or 26. Patients in both groups will additionally receive oral doses of tamoxifen 20 mg once daily for 5 years, starting on the first day of chemotherapy. Surgery will consist of removal of the remaining tumor (breast-conserving resection or mastectomy) and axillary dissection (Sentinel node biopsy is allowed if the patient is involved in a randomized trial. Radiotherapy is applicated according to standard proceedings of participating center. A second randomization for additional versus no additional postoperative chemotherapy is recommended in ypN+ disease. Patients with disease progression during preoperative therapy, chemotherapy can be stopped and surgery can be performed immediately.
- Conditions
- Primary Breast Cancer
- Being tested
- Adriamycin (Doxorubicin), Docetaxel, Tamoxifen, Adriamycin (Doxorubicin), Docetaxel, Tamoxifen, Cyclophosphamid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adriamycin (Doxorubicin), Docetaxel, TamoxifenDrug
Adriamycin will be given at a dose 50 mg/m2 and docetaxel at a dose of 75 mg/m2 every 14 days for four cycles.Tamoxifen 20 mg is given once daily for five years to all patients, starting with the first day of chemotherapy.
Adriamycin (Doxorubicin), Docetaxel, Tamoxifen, CyclophosphamidDrug
Adriamycin will be given at a dose of 60 mg/m2 and cyclophosphamide at a dose of 600 mg/m2 every 21 days for four cycles. Thereafter, docetaxel at a dose of 100 mg/m2 is given every 21 days for four cycles. Tamoxifen 20 mg is given once daily for five years to all patients, starting with the first day of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| ADOC x 4 + Tam 20 | Experimental | Adriamycin will be given at a dose of 50 mg/m2 and docetaxel at a dose of 75 mg/m2 every 14 days for four cycles. Adriamycin will be administered as a short i.v. infusion over 15 minutes, followed immediately by a 1-hour infusion of docetaxel diluted in 250 mL NaCl. Tamoxifen 20 mg is given once daily for five years to all patients, starting with the first day of chemotherapy. Receives: Drug: Adriamycin (Doxorubicin), Docetaxel, Tamoxifen |
| AC x 4 - Doc x 4 + Tam 20 | Experimental | Adriamycin will be given at a dose of 60 mg/m2 and cyclophosphamide at a dose of 600 mg/m2 every 21 days for four cycles. Thereafter, docetaxel at a dose of 100 mg/m2 is given every 21 days for four cycles. Tamoxifen 20 mg is given once daily for five years to all patients, starting with the first day of chemotherapy Receives: Drug: Adriamycin (Doxorubicin), Docetaxel, Tamoxifen, Cyclophosphamid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological locoregional complete tumor response (pCR) between both arms
Measured: 3 years
Secondary outcomes (1)
Survival Local tumor response by palpation (cRR=cCR+cPR) Local tumor response by best imaging method (iRR=iCR+iPR) Response of axillary lymphnodes (NR) Breast conservation therapy (BCT) Toxicity
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study completionSep 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Primary 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 913 participants (actual)
Sponsor and investigators
- Lead sponsor
- GBG Forschungs GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- German Adjuvant Breast Cancer Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793377
- Sponsor's protocol ID
- Gepar-Duo
- Status last verified
- Nov 2008
- First submitted
- 17 Nov 2008
- Last updated
- 19 Nov 2008
- Results posted
- No
Publications
Jackisch C, von Minckwitz G, Eidtmann H, Costa SD, Raab G, Blohmer JU, Schutte M, Gerber B, Merkle E, Gademann G, Lampe D, Hilfrich J, Tulusan AH, Caputo A, Kaufmann M. Dose-dense biweekly doxorubicin/docetaxel versus sequential neoadjuvant chemotherapy with doxorubicin/cyclophosphamide/docetaxel in operable breast cancer: second interim analysis. Clin Breast Cancer. 2002 Oct;3(4):276-80. doi: 10.3816/cbc.2002.n.031.
PubMed 12425756Loibl S, von Minckwitz G, Raab G, Blohmer JU, Dan Costa S, Gerber B, Eidtmann H, Petrich S, Hilfrich J, Jackisch C, du Bois A, Kaufmann M. Surgical procedures after neoadjuvant chemotherapy in operable breast cancer: results of the GEPARDUO trial. Ann Surg Oncol. 2006 Nov;13(11):1434-42. doi: 10.1245/s10434-006-9011-2. Epub 2006 Sep 17.
PubMed 16983592von Minckwitz G, Raab G, Caputo A, Schutte M, Hilfrich J, Blohmer JU, Gerber B, Costa SD, Merkle E, Eidtmann H, Lampe D, Jackisch C, du Bois A, Kaufmann M. Doxorubicin with cyclophosphamide followed by docetaxel every 21 days compared with doxorubicin and docetaxel every 14 days as preoperative treatment in operable breast cancer: the GEPARDUO study of the German Breast Group. J Clin Oncol. 2005 Apr 20;23(12):2676-85. doi: 10.1200/JCO.2005.05.078.
PubMed 15837982von 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 22508812Darb-Esfahani S, Loibl S, Muller BM, Roller M, Denkert C, Komor M, Schluns K, Blohmer JU, Budczies J, Gerber B, Noske A, du Bois A, Weichert W, Jackisch C, Dietel M, Richter K, Kaufmann M, von Minckwitz G. Identification of biology-based breast cancer types with distinct predictive and prognostic features: role of steroid hormone and HER2 receptor expression in patients treated with neoadjuvant anthracycline/taxane-based chemotherapy. Breast Cancer Res. 2009;11(5):R69. doi: 10.1186/bcr2363.
PubMed 19758440
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open Phase III Study Comparing a Dose-Intensified 8 Week Schedule of Adriamycin and Docetaxel (ADOC) With a Sequential 24 Week Schedule of Adriamycin/Cyclophosphamide Followed by Docetaxel (AC-DOC) Regimen as Preoperative Therapy in Patients With Operable Carcinoma of the Breast (T2-3 N0-2 M0)
- ClinicalTrials.gov ID
- NCT00793377
- Acronym / sponsor ID
- Gepar-Duo
- Conditions
- Primary Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 913 participants (actual)
- Lead sponsor
- GBG Forschungs GmbHUniversity, hospital or other
- Collaborators
- German Adjuvant Breast Cancer Group
- Study completion
- Sep 2001 (actual)
- First posted
- 19 Nov 2008 (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.
The primary objective of this trial is to compare the rate of pathologically complete remissions achieved using a preoperative dose-intensified 8 week therapy consisting of adriamycin and docetaxel with a preoperative sequential 24 week regimen consisting of adriamycin/cyclophosphamide followed by docetaxel, in patients with operable carcinoma of the breast. Secondary aims are to assess disease-free and overall survival, the rate of complete and partial responses by palpation and imaging methods, the rate of breast-conserving operations, and the toxicity of the two chemotherapy regimens.
Women meeting the following criteria will be eligible for the study: those with operable breast cancer (T2-3 N0-2 M0), with the diagnosis histologically confirmed by biopsy, and measurable disease on mammography or sonography or breast MRI (the most appropriate method should be chosen by the investigator). After the patients have given written informed consent, they will be randomly assigned to the study treatments. Patients in group I will receive four cycles of combination chemotherapy consisting of adriamycin 50 mg/m2 (15 min i.v. infusion) and docetaxel 75 mg/m2 (1 h i.v. infusion) repeated every 14 days, followed by surgery 9-10 weeks after the start of therapy. Patients in group II will receive four cycles of adriamycin 60 mg/m2 (15 min i.v.) and cyclophosphamide 600 mg/m2 (1 h i.v.) every three weeks, followed by four cycles of docetaxel 100 mg/m2 (1 h i.v.) every three weeks. Surgery will be performed during week 25 or 26. Patients in both groups will additionally receive oral doses of tamoxifen 20 mg once daily for 5 years, starting on the first day of chemotherapy. Surgery will consist of removal of the remaining tumor (breast-conserving resection or mastectomy) and axillary dissection (Sentinel node biopsy is allowed if the patient is involved in a randomized trial. Radiotherapy is applicated according to standard proceedings of participating center. A second randomization for additional versus no additional postoperative chemotherapy is recommended in ypN+ disease. Patients with disease progression during preoperative therapy, chemotherapy can be stopped and surgery can be performed immediately.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADOC x 4 + Tam 20 | Experimental | Drug: Adriamycin (Doxorubicin), Docetaxel, TamoxifenAdriamycin will be given at a dose of 50 mg/m2 and docetaxel at a dose of 75 mg/m2 every 14 days for four cycles. Adriamycin will be administered as a short i.v. infusion over 15 minutes, followed immediately by a 1-hour infusion of docetaxel diluted in 250 mL NaCl. Tamoxifen 20 mg is given once daily for five years to all patients, starting with the first day of chemotherapy. |
| AC x 4 - Doc x 4 + Tam 20 | Experimental | Drug: Adriamycin (Doxorubicin), Docetaxel, Tamoxifen, CyclophosphamidAdriamycin will be given at a dose of 60 mg/m2 and cyclophosphamide at a dose of 600 mg/m2 every 21 days for four cycles. Thereafter, docetaxel at a dose of 100 mg/m2 is given every 21 days for four cycles. Tamoxifen 20 mg is given once daily for five years to all patients, starting with the first day of chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Pre-study screening performed according to section 7.1
- Unilateral primary carcinoma of the breast, confirmed histologically by core or tru-cut biopsy. Fine-needle aspiration is not sufficient. Incisional biopsy is only allowed if less than 20% of the tumor is excised.
- Two-dimensionally measurable (mammography, ultrasound, or MRI) breast tumor
- Primary tumor >= 2 cm in largest diameter by either palpation, sonography or mammography, or breast MRI. In patients with multifocal or multicentric breast cancer, the largest lesion should be measured.
- No evidence of distant metastases
Key exclusion criteria (8 listed)
- Locally advanced (stage T4), bilateral, metastatic, or inflammatory breast cancer. If one of these conditions is suspected, it has to be excluded before enrollment into study.
- Previous treatment for breast cancer, including surgery, radiation, cytotoxic, or endocrine treatments.
- Previous malignancy other than breast cancer or noninvasive breast cancer if the disease-free interval is less than 10 years.
- Previous cytotoxic treatment for any condition.
- Preexisting neurotoxicity greater than grade II.
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 |
|---|---|---|
| Adriamycin (Doxorubicin), Docetaxel, TamoxifenAdriamycin will be given at a dose 50 mg/m2 and docetaxel at a dose of 75 mg/m2 every 14 days for four cycles.Tamoxifen 20 mg is given once daily for five years to all patients, starting with the first day of chemotherapy. | Drug | ADOC x 4 + Tam 20 |
| Adriamycin (Doxorubicin), Docetaxel, Tamoxifen, CyclophosphamidAdriamycin will be given at a dose of 60 mg/m2 and cyclophosphamide at a dose of 600 mg/m2 every 21 days for four cycles. Thereafter, docetaxel at a dose of 100 mg/m2 is given every 21 days for four cycles. Tamoxifen 20 mg is given once daily for five years to all patients, starting with the first day of chemotherapy. | Drug | AC x 4 - Doc x 4 + Tam 20 |
Primary outcome
Pathological locoregional complete tumor response (pCR) between both arms
Time frame: 3 years
1 secondary outcome
Survival Local tumor response by palpation (cRR=cCR+cPR) Local tumor response by best imaging method (iRR=iCR+iPR) Response of axillary lymphnodes (NR) Breast conservation therapy (BCT) Toxicity
Time frame: 3 years
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 19 Nov 2008.
- Background: PubMed 12425756Jackisch C, von Minckwitz G, Eidtmann H, Costa SD, Raab G, Blohmer JU, Schutte M, Gerber B, Merkle E, Gademann G, Lampe D, Hilfrich J, Tulusan AH, Caputo A, Kaufmann M. Dose-dense biweekly doxorubicin/docetaxel versus sequential neoadjuvant chemotherapy with doxorubicin/cyclophosphamide/docetaxel in operable breast cancer: second interim analysis. Clin Breast Cancer. 2002 Oct;3(4):276-80. doi: 10.3816/cbc.2002.n.031.
- Results publication: PubMed 16983592Loibl S, von Minckwitz G, Raab G, Blohmer JU, Dan Costa S, Gerber B, Eidtmann H, Petrich S, Hilfrich J, Jackisch C, du Bois A, Kaufmann M. Surgical procedures after neoadjuvant chemotherapy in operable breast cancer: results of the GEPARDUO trial. Ann Surg Oncol. 2006 Nov;13(11):1434-42. doi: 10.1245/s10434-006-9011-2. Epub 2006 Sep 17.
- Results publication: PubMed 15837982von Minckwitz G, Raab G, Caputo A, Schutte M, Hilfrich J, Blohmer JU, Gerber B, Costa SD, Merkle E, Eidtmann H, Lampe D, Jackisch C, du Bois A, Kaufmann M. Doxorubicin with cyclophosphamide followed by docetaxel every 21 days compared with doxorubicin and docetaxel every 14 days as preoperative treatment in operable breast cancer: the GEPARDUO study of the German Breast Group. J Clin Oncol. 2005 Apr 20;23(12):2676-85. doi: 10.1200/JCO.2005.05.078.
- 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.
- Derived from this study: PubMed 19758440Darb-Esfahani S, Loibl S, Muller BM, Roller M, Denkert C, Komor M, Schluns K, Blohmer JU, Budczies J, Gerber B, Noske A, du Bois A, Weichert W, Jackisch C, Dietel M, Richter K, Kaufmann M, von Minckwitz G. Identification of biology-based breast cancer types with distinct predictive and prognostic features: role of steroid hormone and HER2 receptor expression in patients treated with neoadjuvant anthracycline/taxane-based chemotherapy. Breast Cancer Res. 2009;11(5):R69. doi: 10.1186/bcr2363.
- Related InfoLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adriamycin (Doxorubicin), Docetaxel, Tamoxifen and Adriamycin (Doxorubicin), Docetaxel, Tamoxifen, Cyclophosphamid in people with Primary Breast Cancer, run by GBG Forschungs GmbH at 1 site in Germany.
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 13 inclusion and 8 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 19 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Pathological locoregional complete tumor response (pCR) between both arms (time frame: 3 years). 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 NCT00793377, which also lists 5 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 19 Nov 2008.