Breast NeoplasmsPhase 2NCT00543829
German Preoperative Adriamycin Docetaxel Study
A Phase 2 study testing doxorubicin, docetaxel, tamoxifen and doxorubicin, docetaxel in people with Breast Neoplasms, run by GBG Forschungs GmbH.
Trial summary
The primary objective of this trial is to determine the rate of pathologically complete remissions following a preoperative dose-intensified therapy with doxorubicin and docetaxel with or without tamoxifen in patients with operable carcinoma of the breast. 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?
- doxorubicin, docetaxel, tamoxifen and doxorubicin, docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Apr 1998to Jun 1999
- Phase
- Phase 2
- 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
- Unilateral primary carcinoma of the breast, confirmed histologically by core-cut needle or incisional biopsy. Fine needle aspiration is not sufficient.
- Bidimensionally measurable tumour, either by mammography or breast ultrasound or breast MRI
- Primary tumour >= 3 cm in largest diameter. In patients with multifocal or multicentric breast cancer the largest lesion should be measured.
- No evidence of distant metastases (as confirmed by chest x-ray, liver ultrasound and bone scintigraphy)
- Age >= 18 years and <= 70 years.
- Life expectancy at least 10 years, ignoring the diagnosis of cancer.
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- Karnofsky index >=70%.
- Adequate haematologic, renal and hepatic function (WBC >4000, platelets >100000, bilirubin, serum creatinine and transaminases within the normal range).
- Anamnestic and electrocardiographic evidence of normal cardiac function, without or with medication. Normal cardiac function measured by echocardiography or MUGA-scan.
- Negative pregnancy test and appropriate non-hormonal contraception in fertile women.
- Written informed consent and presumed compliance of the patients.
Who cannot join
- Locally advanced (stage T4), bilateral, metastatic, or inflammatory breast cancer (tethering or dimpling of the skin as well as nipple inversion may not easily be interpreted as skin infiltration). If one of these conditions is suspected it has to be excluded before enrollment onto study.
- Previous treatment for breast cancer, including surgery, radiation, cytotoxic or endocrine treatments. Surgical diagnostic procedures are allowed.
- Previous malignancy other than breast cancer or non-invasive breast lesions if the disease-free interval is less than 10 years.
- Previous cytotoxic treatment for any condition.
- Preexisting neurotoxicity greater than grade II (WHO).
- Active infection or other significant illness that could influence 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.
About this study
Official title: A Randomised, Controlled, Open Phase II b Study Comparing a Combination of Dose-Intensified Doxorubicin and Docetaxel With or Without Tamoxifen as Preoperative Therapy in Patients With Operable Carcinoma of the Breast (T>=3cm N0-2 M0)
The primary objective of this trial is to determine the rate of pathologically complete remissions following a preoperative dose-intensified therapy with doxorubicin and docetaxel with or without tamoxifen in patients with operable carcinoma of the breast. Secondary aims are to assess the rate of clinical complete and partial responses, of breast-conserving operations, and the toxicity of chemotherapy with and without tamoxifen.
Women meeting the following criteria will be eligible for the study: operable breast cancer (T³3cm N0-2 M0), histologically confirmed diagnosis by core-cut needle or incisional biopsy, and measurable disease by mammography or sonography or breast MRI (best appropriate method has to chosen by investigator). After the patients have given written informed consent, they will be randomised to the study treatments. All patients are scheduled to receive 4 cycles of combination chemotherapy consisting of doxorubicin 50 mg/m² (15-min i.v. infusion) and docetaxel 75 mg/m² (1-h i.v. infusion). The patients allocated to group I additionally receive oral doses of tamoxifen 30 mg once daily, starting on the first day of chemotherapy, while chemotherapy alone is administered to patients of group II. Cycles should be repeated every 14 days, followed by surgery 8 weeks after initiation of the trial. Surgery consists of removal of the remaining tumour (breastconserving resection or mastectomy) and axillary dissection. Patients with no response or even progression of the primary tumour can be treated to the discretion of the investigator but should be followed up according to protocol. If a partial or complete tumour response has been achieved, radiotherapy is given to the remaining breast in patients undergoing breast conserving therapy, and tamoxifen treatment is continued for a further 5 years.
Response will be assessed between the 4th cycle and surgery, using the best appropriate method. Clinical evaluation should be performed after each cycle. It is planned to recruite 200 patients during a period of 1 year.
- Conditions
- Breast Neoplasms
- Being tested
- doxorubicin, docetaxel, tamoxifen, doxorubicin, docetaxel
- Keywords
- breast cancer, doxorubicin, docetaxel, tamoxifen
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxorubicin, docetaxel, tamoxifenDrug
Every 14 days to a total of 4 cycles of doxorubicin (50 mg/m², 15 minutes i.v. infusion) and docetaxel (75 mg/m², 1 hour i.v. infusion) with tamoxifen (30 mg tablet p.o. for 5 years post surgery)
doxorubicin, docetaxelDrug
Every 14 days to a total of 4 cycles of doxorubicin (50 mg/m², 15 minutes i.v. infusion) and docetaxel (75 mg/m², 1 hour i.v. infusion)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 4 cycles of doxorubicin and docetaxel with tamoxifen Receives: Drug: doxorubicin, docetaxel, tamoxifen |
| 2 | Active comparator | 4 cycles of doxorubicin and docetaxel without tamoxifen Receives: Drug: doxorubicin, docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is defined as no microscopic evidence of viable tumour in the resected breast specimen
Measured: Post surgery
Secondary outcomes (3)
Endpoints are (1) clinical partial or complete response and (2) clinical complete response
Measured: Post surgery
Endpoint is breast conservation without the need for autologous or heterologous reconstruction
Measured: Post surgery
Endpoints are the frequency of grade III and IV haematological and non-haematological toxicities during chemotherapy and delayed cardiotoxicity
Measured: 2 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2007 (estimated)
- Study startApr 1998
- Study completionJun 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- GBG Forschungs GmbH
- Sponsor type
- University, hospital or other
- Investigators
- Manfred Kaufmann, MD, Principal investigator, J. W. Goethe University, School of Medicine, Dep. of Gynecology and Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543829
- Sponsor's protocol ID
- Gepardo
- Status last verified
- Oct 2007
- First submitted
- 12 Oct 2007
- Last updated
- 17 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
von Minckwitz G, Sinn HP, Raab G, Loibl S, Blohmer JU, Eidtmann H, Hilfrich J, Merkle E, Jackisch C, Costa SD, Caputo A, Kaufmann M; German Breast Group. Clinical response after two cycles compared to HER2, Ki-67, p53, and bcl-2 in independently predicting a pathological complete response after preoperative chemotherapy in patients with operable carcinoma of the breast. Breast Cancer Res. 2008;10(2):R30. doi: 10.1186/bcr1989. Epub 2008 Apr 1.
PubMed 18380893
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Open Phase II b Study Comparing a Combination of Dose-Intensified Doxorubicin and Docetaxel With or Without Tamoxifen as Preoperative Therapy in Patients With Operable Carcinoma of the Breast (T>=3cm N0-2 M0)
- ClinicalTrials.gov ID
- NCT00543829
- Acronym / sponsor ID
- Gepardo
- Conditions
- Breast Neoplasms
- Keywords
- breast cancer, doxorubicin, docetaxel, tamoxifen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- GBG Forschungs GmbHUniversity, hospital or other
- Study start
- Apr 1998
- Study completion
- Jun 1999 (actual)
- First posted
- 15 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.
The primary objective of this trial is to determine the rate of pathologically complete remissions following a preoperative dose-intensified therapy with doxorubicin and docetaxel with or without tamoxifen in patients with operable carcinoma of the breast. Secondary aims are to assess the rate of clinical complete and partial responses, of breast-conserving operations, and the toxicity of chemotherapy with and without tamoxifen.
Women meeting the following criteria will be eligible for the study: operable breast cancer (T³3cm N0-2 M0), histologically confirmed diagnosis by core-cut needle or incisional biopsy, and measurable disease by mammography or sonography or breast MRI (best appropriate method has to chosen by investigator). After the patients have given written informed consent, they will be randomised to the study treatments. All patients are scheduled to receive 4 cycles of combination chemotherapy consisting of doxorubicin 50 mg/m² (15-min i.v. infusion) and docetaxel 75 mg/m² (1-h i.v. infusion). The patients allocated to group I additionally receive oral doses of tamoxifen 30 mg once daily, starting on the first day of chemotherapy, while chemotherapy alone is administered to patients of group II. Cycles should be repeated every 14 days, followed by surgery 8 weeks after initiation of the trial. Surgery consists of removal of the remaining tumour (breastconserving resection or mastectomy) and axillary dissection. Patients with no response or even progression of the primary tumour can be treated to the discretion of the investigator but should be followed up according to protocol. If a partial or complete tumour response has been achieved, radiotherapy is given to the remaining breast in patients undergoing breast conserving therapy, and tamoxifen treatment is continued for a further 5 years.
Response will be assessed between the 4th cycle and surgery, using the best appropriate method. Clinical evaluation should be performed after each cycle. It is planned to recruite 200 patients during a period of 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: doxorubicin, docetaxel, tamoxifen4 cycles of doxorubicin and docetaxel with tamoxifen |
| 2 | Active comparator | Drug: doxorubicin, docetaxel4 cycles of doxorubicin and docetaxel without tamoxifen |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Unilateral primary carcinoma of the breast, confirmed histologically by core-cut needle or incisional biopsy. Fine needle aspiration is not sufficient.
- Bidimensionally measurable tumour, either by mammography or breast ultrasound or breast MRI
- Primary tumour >= 3 cm in largest diameter. In patients with multifocal or multicentric breast cancer the largest lesion should be measured.
- No evidence of distant metastases (as confirmed by chest x-ray, liver ultrasound and bone scintigraphy)
- Age >= 18 years and <= 70 years.
Key exclusion criteria (8 listed)
- Locally advanced (stage T4), bilateral, metastatic, or inflammatory breast cancer (tethering or dimpling of the skin as well as nipple inversion may not easily be interpreted as skin infiltration). If one of these conditions is suspected it has to be excluded before enrollment onto study.
- Previous treatment for breast cancer, including surgery, radiation, cytotoxic or endocrine treatments. Surgical diagnostic procedures are allowed.
- Previous malignancy other than breast cancer or non-invasive breast lesions if the disease-free interval is less than 10 years.
- Previous cytotoxic treatment for any condition.
- Preexisting neurotoxicity greater than grade II (WHO).
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 |
|---|---|---|
| doxorubicin, docetaxel, tamoxifenEvery 14 days to a total of 4 cycles of doxorubicin (50 mg/m², 15 minutes i.v. infusion) and docetaxel (75 mg/m², 1 hour i.v. infusion) with tamoxifen (30 mg tablet p.o. for 5 years post surgery) | Drug | 1 |
| doxorubicin, docetaxelEvery 14 days to a total of 4 cycles of doxorubicin (50 mg/m², 15 minutes i.v. infusion) and docetaxel (75 mg/m², 1 hour i.v. infusion) | Drug | 2 |
Primary outcome
The primary endpoint is defined as no microscopic evidence of viable tumour in the resected breast specimen
Time frame: Post surgery
3 secondary outcomes
Endpoints are (1) clinical partial or complete response and (2) clinical complete response
Time frame: Post surgery
Endpoint is breast conservation without the need for autologous or heterologous reconstruction
Time frame: Post surgery
Endpoints are the frequency of grade III and IV haematological and non-haematological toxicities during chemotherapy and delayed cardiotoxicity
Time frame: 2 years post surgery
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 17 Oct 2007.
- Derived from this study: PubMed 18380893von Minckwitz G, Sinn HP, Raab G, Loibl S, Blohmer JU, Eidtmann H, Hilfrich J, Merkle E, Jackisch C, Costa SD, Caputo A, Kaufmann M; German Breast Group. Clinical response after two cycles compared to HER2, Ki-67, p53, and bcl-2 in independently predicting a pathological complete response after preoperative chemotherapy in patients with operable carcinoma of the breast. Breast Cancer Res. 2008;10(2):R30. doi: 10.1186/bcr1989. Epub 2008 Apr 1.
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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.
Manfred Kaufmann, MD principal investigator
J. W. Goethe University, School of Medicine, Dep. of Gynecology and Obstetrics
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing doxorubicin, docetaxel, tamoxifen and doxorubicin, docetaxel in people with Breast Neoplasms, 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 11 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 17 Oct 2007. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary endpoint is defined as no microscopic evidence of viable tumour in the resected breast specimen (time frame: Post surgery). 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 NCT00543829, which also lists 1 linked publication.
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 17 Oct 2007.