Human Epidermal Growth Factor 2 Negative Carcinoma of BreastPhase 3Stop&GoNCT01935492
8 Continuous vs 8 Intermittent Cycles in First and Second Line in HER2/Neu Neg Metastatic Breast Cancer
A Phase 3 study testing Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine in people with Human Epidermal Growth Factor 2 Negative Carcinoma of Breast and Metastatic Breast Cancer, run by Borstkanker Onderzoek Groep at 1 site in Netherlands.
Trial summary
An open randomized phase III study to compare 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first line treatment, in combination with bevacizumab, and second line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Metastatic Breast Cancer
- What is being tested?
- Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2010to 1 Apr 2019
- 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
- Female patients ≥ 18 years old.
- Patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer, who are candidates for chemotherapy.
- Patients with measurable or evaluable-only (RECIST 1.1)
- Documented Estrogen Receptor (ER) / Progesteron Receptor (PR) status.
- HER2/neu-negative disease
- Patients with an ECOG Performance Status ≤ 2.
- Life expectancy of > 12 weeks.
- Signature of Informed Consent Form
Who cannot join
- Previous chemotherapy for HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer.
- Prior hormonal therapy for HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer that has not been discontinued 1 week before start of study treatment.
- Prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to first study treatment. However, if the prior adjuvant/neo-adjuvant chemotherapy was taxane based, patients are excluded if they received their last chemotherapy within12 months prior to first study treatment.
- Prior radiotherapy covering more than 30% of marrow-bearing bone.
- Patients that have received recent radiation therapy that are not recovered from any significant (Grade ≥ 3) acute toxicity prior to study treatment.
- Prior therapy with bevacizumab, sorafenib, sunitinib, or other VEGF pathway-targeted therapy.
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- Chronic daily treatment with aspirin
- Chronic daily treatment with corticosteroids, with the exception of inhaled steroids.
- Current or recent treatment with another investigational drug or participation in another investigational study.
- Inadequate bone marrow, liver, renal function
- INR > 1.5 or an aPTT > 1.5 x ULN within 7 days prior to first study treatment.
- Known CNS disease, except for treated brain metastases.
- Patients with concurrent active malignancy
- Pregnant or lactating
- Women of childbearing potential not using effective, non-hormonal means of contraception
- Major surgical procedure (including open biopsy) within 28 days prior to the first study treatment
- Core biopsy or other minor surgical procedure, within 7 days prior to day 1.
- Significant vascular disease within 6 months prior to day 1.
- Any previous venous thrombo-embolism > CTC Grade 3.
- History of haemoptysis
- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
- Uncontrolled hypertension
- Clinically significant (i.e. active) cardiovasculair disease
- LVEF by MUGA or ECHO < 50%.
- History of abdominal fistula, Grade 4 bowel obstruction or GI perforation, intra-abdominal abscess within 6 months of randomization.
- Serious non-healing wound, peptic ulcer or bone fracture.
- Known hypersensitivity to any of the study drugs or excipients.
- Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
- Psychiatric illness, physical examination or laboratory findings that may interfer with protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 8 Continuous vs 8 Intermittent Cycles in First and Second Line Treatment of Patients With HER2/Neu Negative, Incurable, Metastatic or Unresectable Locally Advanced Breast Cancer.
An open randomized phase III study to compare 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first line treatment, in combination with bevacizumab, and second line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer.
Read the detailed description
The primary goal of this non-inferiority trial is to determine if the results obtained with a intermittent chemotherapy regimen (2 x 4 cycles of paclitaxel) are not inferior to the results of a continuous chemotherapy regimen (8 cycles of paclitaxel), both combined with bevacizumab in first line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer.
- Being tested
- Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine
- Keywords
- metastatic breast cancer, HER2/neu negative, paclitaxel, bevacizumab, liposomal doxorubicine, capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel, Bevacizumab, liposomal doxorubicin, CapecitabineDrug
Also called Non-pegylated liposomal doxorubicin (Myocet®)
- st line:
- Paclitaxel and bevacizumab: 8 cycles, unless PD or unacceptable toxicity occurs earlier.
- Bevacizumab until PD or unacceptable toxicity
- At PD patients will go to the 2nd treatment line.
- nd line:
- Non-pegylated liposomal doxorubicin (Myocet®) (or capecitabine): 8 cycles, unless PD or unacceptable toxicity occurs earlier.
- At PD patients will go to the 3rd treatment line. If possible, it is advised to cross-over from 2nd line non-pegylated liposomal doxorubicin to 3rd line capecitabine.
Paclitaxel, Bevacizumab, liposomal doxorubicin, CapecitabineDrug
Also called Non-pegylated liposomal doxorubicin (Myocet®):
Arm B
- st line
- Paclitaxel and bevacizumab: 4 cycles, unless PD or unacceptable toxicity
- Bevacizumab until PD or unacceptable toxicity
- At PD < 3 months after last paclitaxel start 2nd treatment line.
- At PD ≥ 3 months after last paclitaxel, start another 4 cycles
- Bevacizumab until the next PD or unacceptable toxicity
- At the next PD start the 2nd treatment line.
- nd line:
- Myocet® or capecitabine: 4 cycles, unless PD or unacceptable toxicity
- At PD < 3 months start the 3rd treatment line. If possible, advised to cross-over from 2nd line Myocet® to 3rd line capecitabine.
- At PD ≥ 3 months after last administration of Myocet® or capecitabine, start another 4 cycles of Myocet® or capecitabine
- At the next PD start 3rd treatment line.
| Study group | Role | What they receive |
|---|---|---|
| 8 cycles of Paclitaxel & bevacizumab | Active comparator | 8 cycles of Paclitaxel: 90 mg/m2 IV on days 1, 8 and 15 every 28 days \& Bevacizumab: 10 mg/kg IV on days 1 and 15 every 28 days Receives: Drug: Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine |
| 2 x 4 cycles of Paclitaxel & bevacizumab | Active comparator | intermittent 2x4 cycles of Paclitaxel: 90 mg/m2 IV on days 1, 8 and 15 every 28 days \& Bevacizumab: 10 mg/kg IV on days 1 and 15 every 28 days Receives: Drug: Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
PFS is defined as the time from start of treatment to the documented progression that requires the patient to switch to the next treatment line or to death due to any cause.
Measured: 1 year
Secondary outcomes (7)
Progression free survival second line treatment
To compare the PFS of second line treatment of 8 continuous cycles of chemotherapy with liposomal doxorubicin (or capecitabine) with 8 cycles of intermittent (2 times 4 cycles) chemotherapy with liposomal doxorubicin (or capecitabine);
Measured: 1 year
Objective overall response rate
To compare the objective Overall Response Rate (ORR) between 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first treatment line, combined with bevacizumab, and in second treatment line.
ORR calculated as the proportion of patients with a best overall response of confirmed Complete Response (CR) and Partial Response (PR).
Measured: 1 year
Duration of objective response
To compare the Duration of Objective Response (DOR) between 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first treatment line, combined with bevacizumab, and second treatment line; For the intermittent chemotherapy schedule the first DOR and, if applicable, second DOR in the same treatment line will be accumulated DOR calculated as the time from the date of first documented CR or PR to the first documented progression or death due to underlying cancer
Measured: 1 year
Overall survival
To compare Overall Survival (OS) between 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy.
OS calculated as the time from the date of randomization to the date of death due to any cause or the date of last contact
Measured: 1 year
Safety and tolerability. The total number of grade 3 and 4 adverse events will be analyzed.
To compare the Safety between 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy The total number of grade 3 and 4 adverse events will be analyzed as a measure of safety and tolerability
Measured: 1 year
Quality of life measures
To compare the Quality of Life (QoL) between 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy.
Changes in the RAND 36 quality of life scale will be measured
Measured: 1 year
Pharmacoeconomics
To compare the Pharmacoeconomics between 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy.
Direct medical costs will be calculated using a standard cost method.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startNov 2010
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Epidermal Growth Factor 2 Negative Carcinoma of BreastStudies 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
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Borstkanker Onderzoek Groep
- Sponsor type
- Research network
- Collaborators
- Roche Pharma AG, Teva Pharma
- Responsible party
- Sponsor
- Investigators
- F.L.G. Erdkamp, PhD, Principal investigator, Orbis Medical CentreM.M.E.M. Bos, PhD, Principal investigator, RdGG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935492
- Sponsor's protocol ID
- BOOG 2010-02 Stop&Go study
- Other IDs
- NTR2589
- Acronym
- Stop&Go
- Status last verified
- Jan 2020
- First submitted
- 26 Nov 2010
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 8 Continuous vs 8 Intermittent Cycles in First and Second Line Treatment of Patients With HER2/Neu Negative, Incurable, Metastatic or Unresectable Locally Advanced Breast Cancer.
- ClinicalTrials.gov ID
- NCT01935492
- Acronym / sponsor ID
- Stop&Go / BOOG 2010-02 Stop&Go study
- Keywords
- metastatic breast cancer, HER2/neu negative, paclitaxel, bevacizumab, liposomal doxorubicine, capecitabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Borstkanker Onderzoek GroepResearch network
- Collaborators
- Roche Pharma AG, Teva Pharma
- Study start
- Nov 2010 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 5 Sep 2013 (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.
An open randomized phase III study to compare 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first line treatment, in combination with bevacizumab, and second line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer.
Detailed description
The primary goal of this non-inferiority trial is to determine if the results obtained with a intermittent chemotherapy regimen (2 x 4 cycles of paclitaxel) are not inferior to the results of a continuous chemotherapy regimen (8 cycles of paclitaxel), both combined with bevacizumab in first line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8 cycles of Paclitaxel & bevacizumab | Active comparator | Drug: Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine8 cycles of Paclitaxel: 90 mg/m2 IV on days 1, 8 and 15 every 28 days \& Bevacizumab: 10 mg/kg IV on days 1 and 15 every 28 days |
| 2 x 4 cycles of Paclitaxel & bevacizumab | Active comparator | Drug: Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabineintermittent 2x4 cycles of Paclitaxel: 90 mg/m2 IV on days 1, 8 and 15 every 28 days \& Bevacizumab: 10 mg/kg IV on days 1 and 15 every 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female patients ≥ 18 years old.
- Patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer, who are candidates for chemotherapy.
- Patients with measurable or evaluable-only (RECIST 1.1)
- Documented Estrogen Receptor (ER) / Progesteron Receptor (PR) status.
- HER2/neu-negative disease
Key exclusion criteria (29 listed)
- Previous chemotherapy for HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer.
- Prior hormonal therapy for HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer that has not been discontinued 1 week before start of study treatment.
- Prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to first study treatment. However, if the prior adjuvant/neo-adjuvant chemotherapy was taxane based, patients are excluded if they received their last chemotherapy within12 months prior to first study treatment.
- Prior radiotherapy covering more than 30% of marrow-bearing bone.
- Patients that have received recent radiation therapy that are not recovered from any significant (Grade ≥ 3) acute toxicity prior to 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 |
|---|---|---|
| Paclitaxel, Bevacizumab, liposomal doxorubicin, CapecitabineAlso: Non-pegylated liposomal doxorubicin (Myocet®)1. st line: * Paclitaxel and bevacizumab: 8 cycles, unless PD or unacceptable toxicity occurs earlier. * Bevacizumab until PD or unacceptable toxicity * At PD patients will go to the 2nd treatment line. 2. nd line: * Non-pegylated liposomal doxorubicin (Myocet®) (or capecitabine): 8 cycles, unless PD or unacceptable toxicity occurs earlier. * At PD patients will go to the 3rd treatment line. If possible, it is advised to cross-over from 2nd line non-pegylated liposomal doxorubicin to 3rd line capecitabine. | Drug | 8 cycles of Paclitaxel & bevacizumab |
| Paclitaxel, Bevacizumab, liposomal doxorubicin, CapecitabineAlso: Non-pegylated liposomal doxorubicin (Myocet®):Arm B 1. st line * Paclitaxel and bevacizumab: 4 cycles, unless PD or unacceptable toxicity * Bevacizumab until PD or unacceptable toxicity * At PD < 3 months after last paclitaxel start 2nd treatment line. * At PD ≥ 3 months after last paclitaxel, start another 4 cycles * Bevacizumab until the next PD or unacceptable toxicity * At the next PD start the 2nd treatment line. 2. nd line: * Myocet® or capecitabine: 4 cycles, unless PD or unacceptable toxicity * At PD < 3 months start the 3rd treatment line. If possible, advised to cross-over from 2nd line Myocet® to 3rd line capecitabine. * At PD ≥ 3 months after last administration of Myocet® or capecitabine, start another 4 cycles of Myocet® or capecitabine * At the next PD start 3rd treatment line. | Drug | 2 x 4 cycles of Paclitaxel & bevacizumab |
Primary outcome
Progression free survival
Time frame: 1 year
PFS is defined as the time from start of treatment to the documented progression that requires the patient to switch to the next treatment line or to death due to any cause.
7 secondary outcomes
Progression free survival second line treatment
Time frame: 1 year
Objective overall response rate
Time frame: 1 year
Duration of objective response
Time frame: 1 year
Overall survival
Time frame: 1 year
Safety and tolerability. The total number of grade 3 and 4 adverse events will be analyzed.
Time frame: 1 year
Quality of life measures
Time frame: 1 year
Pharmacoeconomics
Time frame: 1 year
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 18 Jan 2020.
- www.boogstudycenter.nlLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
F.L.G. Erdkamp, PhD principal investigator
Orbis Medical Centre
M.M.E.M. Bos, PhD principal investigator
RdGG
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 Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine in people with Human Epidermal Growth Factor 2 Negative Carcinoma of Breast and Metastatic Breast Cancer, run by Borstkanker Onderzoek Groep at 1 site in Netherlands.
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 29 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 18 Jan 2020. 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 Netherlands. 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?
Progression free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2020.