Breast Cancer FemalePhase 2SOLTI NEOPARPNCT01204125
Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients
A Phase 2 study testing paclitaxel and Iniparib (SAR2405550 -BSI-201) in people with Breast Cancer Female, run by Sanofi at 25 sites in 3 countries.
Trial summary
Primary Objective: to assess the pathological Complete Response (pCR) rate in the breast of patients treated in following combinations: SAR240550 twice-weekly + weekly paclitaxel, SAR240550 weekly+ weekly paclitaxel, and weekly paclitaxel single agent as calibrator. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- paclitaxel and Iniparib (SAR2405550 -BSI-201)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 25 sitesin 3 countries
- Study dates
- Sep 2010to Feb 2017
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed Stage II-IIIA invasive breast cancer eligible for definitive surgery and Estrogen Receptor (ER)-negative, Progesterone receptor (PgR)-negative and Human epidermal growth factor receptor 2 (HER2) non-overexpressing by Immunohistochemistry (IHC) (0+, 1+) or fluorescence in situ hybridization (FISH negative, ratio <1.8) or IHC (2+, 3+) /FISH-negative.
- The primary tumor must be > 2cm in diameter measured by physical examination and mammography (mandatory) plus either echography or Magnetic Resonance Imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate bone marrow reserve
- Adequate liver and renal function.
- Age > or = 18 years
Who cannot join
- Any prior treatment for primary breast cancer.
- Bilateral or multicentric breast cancer.
- Other primary tumors within the previous 5 years, except for adequately controlled limited basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Pre-existing peripheral neuropathy grade > or = 2 as per National Cancer Institute Common Toxicity Criteria for Adverse Event (NCI CTCAE) at randomization.
- Any history of medical (e.g., cardiovascular, uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection) or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with the study participation or administration of the investigational products, or that may interfere with the interpretation of the results
- Pregnancy or breastfeeding women.
Show all 10Show fewer
- Women of childbearing potential (<2 years after the last menstruation) not using effective, non-hormonal means of contraception during the study and for a period of 6 months following the last administration of study drug.
- Requirement for radiation therapy concurrent with study anticancer treatment. Patients who require breast or chest wall radiation therapy after surgery are eligible.
- Known hypersensitivity to any of the study drugs or excipients
- 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
25 sites in 3 countries.
25 sites in 3 countries
Spain15 sites
Investigational Site Number 724001
Barcelona, 08035
Investigational Site Number 724009
Cáceres, 10003
Investigational Site Number 724013
Córdoba, 14004
Investigational Site Number 724006
Islas Baleares, 07014
Investigational Site Number 724012
Jaén, 23007
Investigational Site Number 724002
Lleida, 25198
Investigational Site Number 724005
Madrid, 28033
Investigational Site Number 724016
Madrid, 28041
Investigational Site Number 724007
Reus, 43201
Investigational Site Number 724018
Santiago de Compostela, 15706
Investigational Site Number 724017
Seville, 41009
Investigational Site Number 724010
Seville, 41013
Investigational Site Number 724003
Torrevieja, 03186
Investigational Site Number 724011
Valencia, 46009
Investigational Site Number 724015
Valencia, 46010
France6 sites
Investigational Site Number 250001
Besançon, 25030
Investigational Site Number 250004
Bordeaux, 33076
Investigational Site Number 250006
Bron, 69677
Investigational Site Number 250003
Paris, 75475
Investigational Site Number 250002
Toulouse, 31052
Investigational Site Number 250005
Villejuif, 94805
Germany4 sites
Investigational Site Number 276002
Cologne, 50931
Investigational Site Number 276003
Erlangen, 91054
Investigational Site Number 276004
Hamburg, 20357
Investigational Site Number 276001
Mönchengladbach, 41061
About this study
Official title: Randomized, Open-label, Phase 2 Study of the Efficacy and Safety of Weekly Paclitaxel Single-agent and Two Different Regimens of the PARP-1 Inhibitor SAR240550 (BSI-201) in Combination With Weekly Paclitaxel, as Neoadjuvant Therapy in Patients With Stage II-IIIA Triple Negative Breast Cancer (TNBC)
Primary Objective:
- to assess the pathological Complete Response (pCR) rate in the breast of patients treated in following combinations: SAR240550 twice-weekly + weekly paclitaxel, SAR240550 weekly+ weekly paclitaxel, and weekly paclitaxel single agent as calibrator.
Read more
Secondary objectives are:
- pCR rate in the breast and axilla,
- Radiological/clinical objective response rate (ORR), breast conservation rate, disease free survival (DFS), and overall survival (OS), in each treatment arm,
- Safety profiles of study combinations and of the single agent reference treatment,
- Molecular characteristics of the tumor tissue and peripheral blood mononuclear cells (PBMC) and any correlation between the biological activity of the study treatment and the disease outcome.
Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
Read the detailed description
Active study treatment will be given either as twice weekly administration (Day 1 and Day 4) or as weekly administration (Day 1) for a maximum of 24 infusions for Arm A and for a maximum of 12 infusions for Arm B. In all study arms, treatment will be given until definitive surgery, the first sign of disease progression, unacceptable toxicity or withdrawal of patient consent.
Definitive surgery will be performed within 2 to 4 weeks after the last dose of study treatment.
Patients who complete all the study treatment or who withdraw consent or experience intolerable toxicity will undergo surgery according to local practices.
The cut-off date for the primary analyses will be 30 days after the last study treatment administration or the date of the definitive surgery, whichever comes last.
The maximum follow up for each individual patient will be until death or 5 years after the definitive surgery date whatever happens first.
- Conditions
- Breast Cancer Female
- Being tested
- paclitaxel, Iniparib (SAR2405550 -BSI-201)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
Pharmaceutical form:solution for infusion
Route of administration: intravenous
Iniparib (SAR2405550 -BSI-201)Drug
Pharmaceutical form : solution for infusion
Route of administration :Intravenous
| Study group | Role | What they receive |
|---|---|---|
| SAR240550 twice weekly/ paclitaxel weekly | Experimental | SAR240550 will be administered at the dose of 5.6mg/kg as a 60-min intravenous (IV) infusion. Patients will receive SAR240550 infusions twice weekly (day 1 and day 4; total dose of 11.2mg/kg per week) and paclitaxel weekly as a 60-min IV infusion (day 1; dose of 80mg/m2). Receives: Drug: Iniparib (SAR2405550 -BSI-201) |
| SAR240550 weekly/ paclitaxel weekly | Experimental | SAR240550 will be administered at the dose of 11.2 mg/kg as a 60-min intravenous (IV) infusion. Patients will receive SAR240550 infusions once weekly (day 1; total dose of 11.2mg/kg per week) and paclitaxel weekly as a 60-min IV infusion (day 1; dose of 80mg/m2). Receives: Drug: Iniparib (SAR2405550 -BSI-201) |
| Paclitaxel alone | Active comparator | Paclitaxel will be administered at the dose of 80mg/m2 as a 60-min IV infusion. Patients will receive weekly (day 1) paclitaxel infusions. Receives: Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) rate defined as the complete absence of invasive carcinoma on histological examination of the breast at the time of definitive surgery and confirmed by blinded centralized review
Measured: at the time of definitive surgery
Secondary outcomes (7)
Pathological Complete Response (pCR) rate in the breast and axilla
Measured: at the time of definitive surgery
Objective Response Rate(ORR) defined in the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as complete response rate + partial response rate
Measured: at the time of definitive surgery
Breast conservation rate
Measured: at the time of definitive surgery
Disease Free Survival rate (DFS)
Measured: up to a maximum of 5 years after definitive surgery
Overall Survival (OS)
Measured: up to a maximum of 5 years after definitive surgery
Safety parameters (number of patients AE, SAE or AEPM)
Measured: up to a maximum of 5 years after definitive surgery
Molecular-biological testing
Measured: 2 or 3 timepoints during treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2012
- Study completionFeb 2017
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 Cancer FemaleStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SOLTI Breast Cancer Research Group
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204125
- Sponsor's protocol ID
- TCD11419
- Other IDs
- 2010-018960-17
- Acronym
- SOLTI NEOPARP
- Status last verified
- Mar 2017
- First submitted
- 13 Sep 2010
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Llombart-Cussac A, Bermejo B, Villanueva C, Delaloge S, Morales S, Balmana J, Amillano K, Bonnefoi H, Casas A, Manso L, Roche H, Gonzalez-Santiago S, Gavila J, Sanchez-Rovira P, Di Cosimo S, Harbeck N, Charpentier E, Garcia-Ribas I, Radosevic-Robin N, Aura C, Baselga J. SOLTI NeoPARP: a phase II randomized study of two schedules of iniparib plus paclitaxel versus paclitaxel alone as neoadjuvant therapy in patients with triple-negative breast cancer. Breast Cancer Res Treat. 2015 Nov;154(2):351-7. doi: 10.1007/s10549-015-3616-8. Epub 2015 Nov 4.
PubMed 26536871
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label, Phase 2 Study of the Efficacy and Safety of Weekly Paclitaxel Single-agent and Two Different Regimens of the PARP-1 Inhibitor SAR240550 (BSI-201) in Combination With Weekly Paclitaxel, as Neoadjuvant Therapy in Patients With Stage II-IIIA Triple Negative Breast Cancer (TNBC)
- ClinicalTrials.gov ID
- NCT01204125
- Acronym / sponsor ID
- SOLTI NEOPARP / TCD11419
- Conditions
- Breast Cancer Female
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- SOLTI Breast Cancer Research Group
- Study start
- Sep 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 17 Sep 2010 (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 Objective:
- to assess the pathological Complete Response (pCR) rate in the breast of patients treated in following combinations: SAR240550 twice-weekly + weekly paclitaxel, SAR240550 weekly+ weekly paclitaxel, and weekly paclitaxel single agent as calibrator.
Secondary objectives are:
- pCR rate in the breast and axilla,
- Radiological/clinical objective response rate (ORR), breast conservation rate, disease free survival (DFS), and overall survival (OS), in each treatment arm,
- Safety profiles of study combinations and of the single agent reference treatment,
- Molecular characteristics of the tumor tissue and peripheral blood mononuclear cells (PBMC) and any correlation between the biological activity of the study treatment and the disease outcome.
Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
Detailed description
Active study treatment will be given either as twice weekly administration (Day 1 and Day 4) or as weekly administration (Day 1) for a maximum of 24 infusions for Arm A and for a maximum of 12 infusions for Arm B. In all study arms, treatment will be given until definitive surgery, the first sign of disease progression, unacceptable toxicity or withdrawal of patient consent.
Definitive surgery will be performed within 2 to 4 weeks after the last dose of study treatment.
Patients who complete all the study treatment or who withdraw consent or experience intolerable toxicity will undergo surgery according to local practices.
The cut-off date for the primary analyses will be 30 days after the last study treatment administration or the date of the definitive surgery, whichever comes last.
The maximum follow up for each individual patient will be until death or 5 years after the definitive surgery date whatever happens first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SAR240550 twice weekly/ paclitaxel weekly | Experimental | Drug: Iniparib (SAR2405550 -BSI-201)SAR240550 will be administered at the dose of 5.6mg/kg as a 60-min intravenous (IV) infusion. Patients will receive SAR240550 infusions twice weekly (day 1 and day 4; total dose of 11.2mg/kg per week) and paclitaxel weekly as a 60-min IV infusion (day 1; dose of 80mg/m2). |
| SAR240550 weekly/ paclitaxel weekly | Experimental | Drug: Iniparib (SAR2405550 -BSI-201)SAR240550 will be administered at the dose of 11.2 mg/kg as a 60-min intravenous (IV) infusion. Patients will receive SAR240550 infusions once weekly (day 1; total dose of 11.2mg/kg per week) and paclitaxel weekly as a 60-min IV infusion (day 1; dose of 80mg/m2). |
| Paclitaxel alone | Active comparator | Drug: paclitaxelPaclitaxel will be administered at the dose of 80mg/m2 as a 60-min IV infusion. Patients will receive weekly (day 1) paclitaxel infusions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed Stage II-IIIA invasive breast cancer eligible for definitive surgery and Estrogen Receptor (ER)-negative, Progesterone receptor (PgR)-negative and Human epidermal growth factor receptor 2 (HER2) non-overexpressing by Immunohistochemistry (IHC) (0+, 1+) or fluorescence in situ hybridization (FISH negative, ratio <1.8) or IHC (2+, 3+) /FISH-negative.
- The primary tumor must be > 2cm in diameter measured by physical examination and mammography (mandatory) plus either echography or Magnetic Resonance Imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate bone marrow reserve
- Adequate liver and renal function.
Key exclusion criteria (10 listed)
- Any prior treatment for primary breast cancer.
- Bilateral or multicentric breast cancer.
- Other primary tumors within the previous 5 years, except for adequately controlled limited basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Pre-existing peripheral neuropathy grade > or = 2 as per National Cancer Institute Common Toxicity Criteria for Adverse Event (NCI CTCAE) at randomization.
- Any history of medical (e.g., cardiovascular, uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection) or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with the study participation or administration of the investigational products, or that may interfere with the interpretation of the results
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 |
|---|---|---|
| paclitaxelPharmaceutical form:solution for infusion Route of administration: intravenous | Drug | Paclitaxel alone |
| Iniparib (SAR2405550 -BSI-201)Pharmaceutical form : solution for infusion Route of administration :Intravenous | Drug | SAR240550 twice weekly/ paclitaxel weekly, SAR240550 weekly/ paclitaxel weekly |
Primary outcome
Pathological Complete Response (pCR) rate defined as the complete absence of invasive carcinoma on histological examination of the breast at the time of definitive surgery and confirmed by blinded centralized review
Time frame: at the time of definitive surgery
7 secondary outcomes
Pathological Complete Response (pCR) rate in the breast and axilla
Time frame: at the time of definitive surgery
Objective Response Rate(ORR) defined in the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as complete response rate + partial response rate
Time frame: at the time of definitive surgery
Breast conservation rate
Time frame: at the time of definitive surgery
Disease Free Survival rate (DFS)
Time frame: up to a maximum of 5 years after definitive surgery
Overall Survival (OS)
Time frame: up to a maximum of 5 years after definitive surgery
Safety parameters (number of patients AE, SAE or AEPM)
Time frame: up to a maximum of 5 years after definitive surgery
Molecular-biological testing
Time frame: 2 or 3 timepoints during treatment period
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 22 Mar 2017.
- Derived from this study: PubMed 26536871Llombart-Cussac A, Bermejo B, Villanueva C, Delaloge S, Morales S, Balmana J, Amillano K, Bonnefoi H, Casas A, Manso L, Roche H, Gonzalez-Santiago S, Gavila J, Sanchez-Rovira P, Di Cosimo S, Harbeck N, Charpentier E, Garcia-Ribas I, Radosevic-Robin N, Aura C, Baselga J. SOLTI NeoPARP: a phase II randomized study of two schedules of iniparib plus paclitaxel versus paclitaxel alone as neoadjuvant therapy in patients with triple-negative breast cancer. Breast Cancer Res Treat. 2015 Nov;154(2):351-7. doi: 10.1007/s10549-015-3616-8. Epub 2015 Nov 4.
Related trials for Breast Cancer Female
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
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.
Clinical Sciences & Operations study director
Sanofi
25 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paclitaxel and Iniparib (SAR2405550 -BSI-201) in people with Breast Cancer Female, run by Sanofi at 25 sites in 3 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 6 inclusion and 10 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 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Spain, France, 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 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?
Pathological Complete Response (pCR) rate defined as the complete absence of invasive carcinoma on histological examination of the breast at the time of definitive surgery and confirmed by blinded centralized review (time frame: at the time of definitive 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 NCT01204125, 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 22 Mar 2017.