Breast NeoplasmsPhase 3NCT00174655
BIG 02/98 Docetaxel - Breast Cancer
A Phase 3 study testing Doxorubicine + docetaxel sequential, doxorubicine + cyclophosphamide sequential and doxorubicine + cyclophosphamide combined in people with Breast Neoplasms, run by Sanofi at 21 sites in 21 countries.
Trial summary
Primary objectives: To compare Disease-Free Survival (DFS) of an adjuvant treatment with docetaxel given either sequentially or in combination with doxorubicin and followed by CMF to doxorubicin alone or in combination with cyclophosphamide and followed by CMF in operable breast cancer patients with positive axillary… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Doxorubicine + docetaxel sequential, doxorubicine + cyclophosphamide sequential and doxorubicine + cyclophosphamide combined
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,887 participants
- Where
- 21 sitesin 21 countries
- Study dates
- Jun 1998to Sep 2011
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven breast cancer. Interval between definitive surgery that includes axillary lymph node dissection and registration must be less than 60 days. A representative sample of the primary tumor (either blocks or slides) must be sent to the operational office, for central pathology reviews, after patients randomization.
- Definitive surgical treatment must be either mastectomy or breast conserving surgery, with axillary lymph node dissection (not sampling) for operable breast cancer (clinical T1-3, N0-1, M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin. Patients with histologically-documented infiltration of the skin (pT4) will not be eligible. Patients who have a breast conserving procedure with a positive margin may become eligible if they subsequently undergo adequate resection or mastectomy with clear margins.
- Histologic examination of the tumor: invasive adenocarcinoma with at least one axillary lymph node (pN1) showing evidence of tumor among a minimum of eight resected lymph nodes. All nodes must be examined by the pathologist. The determination of ER (estrogen receptor) and PgR (progesterone receptor) is mandatory and results must be known by the end of chemotherapy in order to decide whether hormonal therapy is indicated (Biochemical or immunohistochemical methods required ; ER and/or PgR positivity should be in accordance with the policy in use at each participating center. Each center will specify its own policy).
- Age > or = 18 years and age < or = 70 years. The upper age limit is not meant to be exclusionary but rather is based on the lack of safety data for women > 70 years of age.
- Karnofsky Performance status index > or = 70 %.
- Normal cardiac function must be confirmed by LVEF (MUGA scan or echocardiography). The result must be above the lower limit of normal for the institution.
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- Laboratory requirements: (within 14 days prior to registration)
- Hematology
- Neutrophils > or = 2.0 x 109/L
- Platelets > or =100 x 109/L
- Hemoglobin > or = 10 g/dL
- Hepatic function
- Total bilirubin < or = 1 UNL
- ASAT (SGOT) and ALAT (SGPT) < or = 1.5 UNL
- Alkaline phosphatase < or = 2.5 UNL
- Renal function
- Creatinine < or = 150 µmol/L (1.5 mg/dL)
- If creatinine is borderline, the calculated creatinine clearance should be > or = 60 mL/min (Cockcroft formula).
- Complete staging work-up within 3 months prior to registration. All patients will have bilateral mammography, chest X-ray (PA and lateral) and/or CT-scan, abdominal ultrasound and/or CT scan, bone scan (in case of positive bone scan suspicious for metastases, bone X-ray (or bone CT-scan for spine) on hot spots is mandatory to rule out the possibility of metastatic hot spots). Other tests may be performed as clinically indicated.
- Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at a participating center which could be a Principal or a co-investigator's site. In case patient moves during the follow-up, every effort should be done to follow the patient in a participating center.
- Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential. Patients of childbearing potential must implement adequate non-hormonal measures to avoid pregnancy during study treatment(chemotherapy, radiotherapy and hormonal therapy).
Who cannot join
- Prior systemic anticancer therapy for breast cancer (chemo-immuno-hormonotherapy).
- Prior radiation therapy for breast cancer.
- Pregnant, or lactating patients.
- Any locally advanced (clinical or pathological T4 and/or N2-known N3) or metastatic(M1) breast cancer.Patients with inoperable residual axillary nodal disease or with supraclavicular nodes.
- Pre-existing motor or sensory neurotoxicity of a severity ³ grade 2 by NCI criteria.
- Other serious illness or medical condition:
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- congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled 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
- Past or current history of other neoplasms except for:
- curatively treated basal cell skin cancer
- adequately treated in situ carcinoma of the cervix
- In regard to past or current history of other breast carcinoma, criteria of exclusion are:
- past history of ipsilateral or past or current history of contralateral invasive breast carcinoma
- past or current history of contralateral ductal in situ breast carcinoma
- A past or current history of ipsilateral ductal in situ or lobular in situ (ipsilateral or contralateral) breast carcinoma is not a criterion of exclusion.
- Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (< or = 20 mg methylprednisolone or equivalent).
- Concurrent treatment with hormonal replacement therapy. Prior treatment should 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.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
21 sites in 21 countries.
21 sites in 21 countries
About this study
Official title: An Intergroup Phase III Trial to Evaluate the Activity of Docetaxel, Given Either Sequentially or in Combination With Doxorubicin, Followed by CMF, in Comparison to Doxorubicin Alone or in Combination With Cyclophosphamide, Followed by CMF, in the Adjuvant Treatment of Node-positive Breast Cancer Patients.
Primary objectives:
- To compare Disease-Free Survival (DFS) of an adjuvant treatment with docetaxel given either sequentially or in combination with doxorubicin and followed by CMF to doxorubicin alone or in combination with cyclophosphamide and followed by CMF in operable breast cancer patients with positive axillary lymph nodes.
Read more
Secondary objectives:
- To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin followed by CMF in operable breast cancer patients with positive axillary lymph nodes
- To compare DFS of an adjuvant treatment with docetaxel in combination with doxorubicin followed by CMF to doxorubicin in combination with cyclophosphamide followed by CMF in operable breast cancer patients with positive axillary lymph nodes
- To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin in combination with docetaxel followed by CMF in operable breast cancer patients with positive axillary lymph nodes, (sequential mono-chemotherapy versus polychemotherapy).
- To compare overall survival of treatment arms.
- To compare toxicity of treatment arms.
- To evaluate pathologic and molecular markers for predicting efficacy.
- Socioeconomic data will be collected in order to be able to perform a socioeconomic analysis by country, when needed.
- Conditions
- Breast Neoplasms
- Being tested
- Doxorubicine + docetaxel sequential, doxorubicine + cyclophosphamide sequential, doxorubicine + cyclophosphamide combined, doxorubicine + docetaxel combined
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxorubicine + docetaxel sequentialDrug
doxorubicin 75 mg/m² i.v. day 1, q 21 days for 3 cycles, followed by docetaxel 100 mg/m² i.v., 1 hour infusion, day 1, q 21 days for 3 cycles, followed by CMF for 3 cycles
doxorubicine + cyclophosphamide sequentialDrug
doxorubicin 75 mg/m² i.v. day 1 q 21 days for 4 cycles, followed by CMF (C: cyclophosphamide 100 mg/m² orally days 1-14, M: methotrexate: 40 mg/m² i.v. days 1 and 8, FU; 5-fluorouracil: 600 mg/m²) i.v. days 1 and 8, q 28 days for 3 cycles
doxorubicine + cyclophosphamide combinedDrug
doxorubicin 60 mg/m² i.v. + cyclophosphamide 600 mg/m² i.v., day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles.
doxorubicine + docetaxel combinedDrug
doxorubicin 50 mg/m² i.v. + docetaxel 75 mg/m² i.v. 1 hour infusion (1 hour after doxorubicin), day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Active comparator | Not described Receives: Drug: doxorubicine + cyclophosphamide sequential |
| A2 | Active comparator | Not described Receives: Drug: doxorubicine + cyclophosphamide combined |
| B | Experimental | Not described Receives: Drug: Doxorubicine + docetaxel sequential |
| C | Experimental | Not described Receives: Drug: doxorubicine + docetaxel combined |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS of docetaxel arms versus non toxanes arm (DFS: interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death for any cause whichever occurs first.
Measured: 810 events or median 5 year follow-up whichever occurs first
Secondary outcomes (2)
DFS sequential/combined arms
Measured: 810 events or median 5 year follow-up whichever occurs first
Safety NCI common toxicity criteria
Measured: from baseline to study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 1998
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- 2,887 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Aussel, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174655
- Sponsor's protocol ID
- RP56976_PR_315
- Status last verified
- Nov 2011
- First submitted
- 9 Sep 2005
- Last updated
- 10 Nov 2011
- Results posted
- No
Publications
Desmedt C, Fornili M, Clatot F, Demicheli R, De Bortoli D, Di Leo A, Viale G, de Azambuja E, Crown J, Francis PA, Sotiriou C, Piccart M, Biganzoli E. Differential Benefit of Adjuvant Docetaxel-Based Chemotherapy in Patients With Early Breast Cancer According to Baseline Body Mass Index. J Clin Oncol. 2020 Sep 1;38(25):2883-2891. doi: 10.1200/JCO.19.01771. Epub 2020 Jul 2.
PubMed 32614702Fernandez-Cuesta L, Oakman C, Falagan-Lotsch P, Smoth KS, Quinaux E, Buyse M, Dolci MS, Azambuja ED, Hainaut P, Dell'orto P, Larsimont D, Francis PA, Crown J, Piccart-Gebhart M, Viale G, Leo AD, Olivier M. Prognostic and predictive value of TP53 mutations in node-positive breast cancer patients treated with anthracycline- or anthracycline/taxane-based adjuvant therapy: results from the BIG 02-98 phase III trial. Breast Cancer Res. 2012 May 2;14(3):R70. doi: 10.1186/bcr3179.
PubMed 22551440
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intergroup Phase III Trial to Evaluate the Activity of Docetaxel, Given Either Sequentially or in Combination With Doxorubicin, Followed by CMF, in Comparison to Doxorubicin Alone or in Combination With Cyclophosphamide, Followed by CMF, in the Adjuvant Treatment of Node-positive Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT00174655
- Acronym / sponsor ID
- RP56976_PR_315
- Conditions
- Breast Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,887 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 1998
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Sep 2005 (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 objectives:
- To compare Disease-Free Survival (DFS) of an adjuvant treatment with docetaxel given either sequentially or in combination with doxorubicin and followed by CMF to doxorubicin alone or in combination with cyclophosphamide and followed by CMF in operable breast cancer patients with positive axillary lymph nodes.
Secondary objectives:
- To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin followed by CMF in operable breast cancer patients with positive axillary lymph nodes
- To compare DFS of an adjuvant treatment with docetaxel in combination with doxorubicin followed by CMF to doxorubicin in combination with cyclophosphamide followed by CMF in operable breast cancer patients with positive axillary lymph nodes
- To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin in combination with docetaxel followed by CMF in operable breast cancer patients with positive axillary lymph nodes, (sequential mono-chemotherapy versus polychemotherapy).
- To compare overall survival of treatment arms.
- To compare toxicity of treatment arms.
- To evaluate pathologic and molecular markers for predicting efficacy.
- Socioeconomic data will be collected in order to be able to perform a socioeconomic analysis by country, when needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 | Active comparator | Drug: doxorubicine + cyclophosphamide sequential |
| A2 | Active comparator | Drug: doxorubicine + cyclophosphamide combined |
| B | Experimental | Drug: Doxorubicine + docetaxel sequential |
| C | Experimental | Drug: doxorubicine + docetaxel combined |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologically proven breast cancer. Interval between definitive surgery that includes axillary lymph node dissection and registration must be less than 60 days. A representative sample of the primary tumor (either blocks or slides) must be sent to the operational office, for central pathology reviews, after patients randomization.
- Definitive surgical treatment must be either mastectomy or breast conserving surgery, with axillary lymph node dissection (not sampling) for operable breast cancer (clinical T1-3, N0-1, M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin. Patients with histologically-documented infiltration of the skin (pT4) will not be eligible. Patients who have a breast conserving procedure with a positive margin may become eligible if they subsequently undergo adequate resection or mastectomy with clear margins.
- Histologic examination of the tumor: invasive adenocarcinoma with at least one axillary lymph node (pN1) showing evidence of tumor among a minimum of eight resected lymph nodes. All nodes must be examined by the pathologist. The determination of ER (estrogen receptor) and PgR (progesterone receptor) is mandatory and results must be known by the end of chemotherapy in order to decide whether hormonal therapy is indicated (Biochemical or immunohistochemical methods required ; ER and/or PgR positivity should be in accordance with the policy in use at each participating center. Each center will specify its own policy).
- Age > or = 18 years and age < or = 70 years. The upper age limit is not meant to be exclusionary but rather is based on the lack of safety data for women > 70 years of age.
- Karnofsky Performance status index > or = 70 %.
Key exclusion criteria (23 listed)
- Prior systemic anticancer therapy for breast cancer (chemo-immuno-hormonotherapy).
- Prior radiation therapy for breast cancer.
- Pregnant, or lactating patients.
- Any locally advanced (clinical or pathological T4 and/or N2-known N3) or metastatic(M1) breast cancer.Patients with inoperable residual axillary nodal disease or with supraclavicular nodes.
- Pre-existing motor or sensory neurotoxicity of a severity ³ grade 2 by NCI criteria.
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 |
|---|---|---|
| Doxorubicine + docetaxel sequentialdoxorubicin 75 mg/m² i.v. day 1, q 21 days for 3 cycles, followed by docetaxel 100 mg/m² i.v., 1 hour infusion, day 1, q 21 days for 3 cycles, followed by CMF for 3 cycles | Drug | B |
| doxorubicine + cyclophosphamide sequentialdoxorubicin 75 mg/m² i.v. day 1 q 21 days for 4 cycles, followed by CMF (C: cyclophosphamide 100 mg/m² orally days 1-14, M: methotrexate: 40 mg/m² i.v. days 1 and 8, FU; 5-fluorouracil: 600 mg/m²) i.v. days 1 and 8, q 28 days for 3 cycles | Drug | A1 |
| doxorubicine + cyclophosphamide combineddoxorubicin 60 mg/m² i.v. + cyclophosphamide 600 mg/m² i.v., day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles. | Drug | A2 |
| doxorubicine + docetaxel combineddoxorubicin 50 mg/m² i.v. + docetaxel 75 mg/m² i.v. 1 hour infusion (1 hour after doxorubicin), day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles. | Drug | C |
Primary outcome
DFS of docetaxel arms versus non toxanes arm (DFS: interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death for any cause whichever occurs first.
Time frame: 810 events or median 5 year follow-up whichever occurs first
2 secondary outcomes
DFS sequential/combined arms
Time frame: 810 events or median 5 year follow-up whichever occurs first
Safety NCI common toxicity criteria
Time frame: from baseline to study end
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 10 Nov 2011.
- Derived from this study: PubMed 32614702Desmedt C, Fornili M, Clatot F, Demicheli R, De Bortoli D, Di Leo A, Viale G, de Azambuja E, Crown J, Francis PA, Sotiriou C, Piccart M, Biganzoli E. Differential Benefit of Adjuvant Docetaxel-Based Chemotherapy in Patients With Early Breast Cancer According to Baseline Body Mass Index. J Clin Oncol. 2020 Sep 1;38(25):2883-2891. doi: 10.1200/JCO.19.01771. Epub 2020 Jul 2.
- Derived from this study: PubMed 22551440Fernandez-Cuesta L, Oakman C, Falagan-Lotsch P, Smoth KS, Quinaux E, Buyse M, Dolci MS, Azambuja ED, Hainaut P, Dell'orto P, Larsimont D, Francis PA, Crown J, Piccart-Gebhart M, Viale G, Leo AD, Olivier M. Prognostic and predictive value of TP53 mutations in node-positive breast cancer patients treated with anthracycline- or anthracycline/taxane-based adjuvant therapy: results from the BIG 02-98 phase III trial. Breast Cancer Res. 2012 May 2;14(3):R70. doi: 10.1186/bcr3179.
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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.
Jean-Philippe Aussel study director
Sanofi
21 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Doxorubicine + docetaxel sequential, doxorubicine + cyclophosphamide sequential and doxorubicine + cyclophosphamide combined in people with Breast Neoplasms, run by Sanofi at 21 sites in 21 countries.
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 21 inclusion and 23 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 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Australia, Austria, Belgium, Brazil, Chile and 16 more countries. 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?
DFS of docetaxel arms versus non toxanes arm (DFS: interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death for any cause whichever occurs first. (time frame: 810 events or median 5 year follow-up whichever occurs first). 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 NCT00174655, which also lists 2 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 10 Nov 2011; AzTrials last refreshed its copy on 6 Nov 2026.