Breast CancerPhase 2NCT01565499
Neoadjuvant Treatment With Nab-paclitaxel for Patients With Stage II and III Luminal Breast Cancer
A Phase 2 study testing Nab-paclitaxel in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 13 sites in Spain.
Trial summary
Multicenter, open label, non-randomized phase 2 trial to evaluate the efficacy and safety of nab-paclitaxel in the neoadjuvant treatment of ER positive human epidermal growth factor receptor 2 (HER2) negative patients amenable to receive neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Nab-paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 13 sitesSpain
- Study dates
- 17 Apr 2012to 27 May 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 with histologically confirmed diagnosis of primary unilateral invasive early breast cancer with longest tumor size in breast ≥ 2cm, or < 2 cm with axillary involvement. In case of a multifocal tumor (tumor foci located in the same quadrant) the largest lesion must be ≥ 2cm (unless axillary involvement) and is designated as the "target" lesion for all subsequent tumor evaluations.
- The breast tumors must be ER positive: more than 1% of stained tumor cells by immuno-histochemistry (IHC), and HER2 negative: 0, or 1+ score by IHC, or 2+ with fluorescence in situ hybridization (FISH)/chromogenic in situ hybridization (CISH) negative for HER2 amplification (defined as a ratio of HER2/neu copies to chromosome 17 centromere (CEP17) signals <1.8), according to the local laboratory).
- Are clear candidates to receive chemotherapy by the investigator criteria.
- Are at least 18 years of age.
- Have at least one unidimensionally measurable lesion by RECIST [65] version 1.1, measured by mammogram.
- Have adequate performance status: Eastern Cooperative Oncology Group (ECOG) <2
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- Have adequate renal and liver function and bone marrow reserve as follows:
- Bone marrow: absolute neutrophil count (ANC) > or = 1.500/mm3 (1.5 x 109/L); platelet count > or = 100.000/mm3 (100.0 x 109/L); and hemoglobin > or = 9 g/dL.
- Hepatic: bilirubin < or = 1.5 times the upper limit of normal (x ULN); alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) < or = 2.5 * ULN and Albumin ≥ 2.5 g/dL.
- Renal: serum creatinine < 1.5 x ULN.
- Exhibit patient compliance and geographic proximity that allow for adequate follow-up
- Entry informed consent form signed by the patient.
Who cannot join
- Inflammatory breast cancer (T4d) and supraclavicular lymph nodes (N3)
- Synchronous contralateral or multicentric breast cancer.
- Clinical or radiologic evidence of metastatic disease. Chest examination by x-ray or CT-scan, abdominal examination by CT-scan, bone examination by bone scan as well as other radiological methods in case of suspicion must be performed before enrollment in order to rule out metastasis.
- Second primary malignancy, except adequately treated carcinoma in situ of the cervix, stage I colon cancer, non-invasive melanoma, basal or squamous cell carcinomas of the skin, ipsilateral ductal carcinoma in-situ (DCIS) of the breast and lobular carcinoma in-situ (LCIS) of the breast; unless that prior malignancy was diagnosed and definitively treated more than 5 years ago with no subsequent evidence of recurrence.
- Prior or concurrent anti-cancer therapy for current disease (hormone therapy, chemotherapy, radiotherapy, immunotherapy, biological therapy other than the trial therapies).
- Concurrent treatment with any hormonal treatment either for osteoporosis or as replacement therapy.
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- Patients with known hypersensitivity to nab-paclitaxel or any of its components.
- Previous neuropathy grade >1 according to the NCI-CTCAE vs 4.03 criteria
- Have received treatment within the last 4 weeks with a drug that has not received regulatory approval for any indication at the time of study entry.
- Have any serious concomitant systemic disorder incompatible with the study (at the discretion of investigator).
- Patient is pregnant or breast feeding or planning to become pregnant within the six months after the end of treatment. Women with child-bearing potential must be performed a pregnancy serum or urine testing within 7 days prior to study entry according to institutional standards and should use an adequate non-hormonal contraceptive method (intra-uterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterilized) during treatment with study drugs and within the six months after the end of treatment.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Hospital Clinic i Provincial
Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Instituto Oncológico de Guipúzcoa
Donostia / San Sebastian, Guipúzcoa, 20012
Complejo Hospitalario de Jaén
Jaén, 23007
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital La Paz
Madrid, 28046
Hospital Universitario Morales Meseguer
Murcia, 30008
Corporación Sanitaria Parc Taulí
Sabadell, Barcelona, 08208
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Hospital Virgen de la Salud
Toledo, 45004
Instituto Valenciano de Oncología
Valencia, 46009
Hospital Miguel Servet
Zaragoza, 50009
About this study
Official title: Phase II, Open-label, Non-randomized Study of Nab-paclitaxel for the Neoadjuvant Treatment of Patients With Stage II and III Luminal Breast Cancer
Multicenter, open label, non-randomized phase 2 trial to evaluate the efficacy and safety of nab-paclitaxel in the neoadjuvant treatment of ER positive human epidermal growth factor receptor 2 (HER2) negative patients amenable to receive neoadjuvant chemotherapy.
Read the detailed description
The primary objective of the trial is to determine the percentage of patients with poor response [residual cancer burden III (RCB-III) rate] in contrast to good response [residual cancer burden 0/I RCB-0/1] measured by the Symmans criteria [20] at surgery, in patients with stage II-III luminal breast cancer treated with neoadjuvant nab-paclitaxel.
The primary endpoint of the study is to determine the residual cancer burden grade III (RCB-III) after surgery.
The total number of patients to be included in this study is 78 patients.
The duration of the study, from first patient visit to last patient visit will be approximately 90 months (Including follow-ups)
- Conditions
- Breast Cancer
- Being tested
- Nab-paclitaxel
- Keywords
- Neoadjuvant nab-paclitaxel luminal breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-paclitaxelDrug
Also called Abraxane
| Study group | Role | What they receive |
|---|---|---|
| Nab-Paclitaxel | Experimental | The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. Receives: Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Residual Cancer Burden Grade III (RCB-III).
The RCB-III was reported, including a 95% confidence interval. The estimate of the RCB-III was calculated as follows:
Overall Response Rate = Number of patients with RCB-III / Intent to treat (ITT) population
Measured: After surgery, up to 4 months
Secondary outcomes (10)
Pathologic Complete Response (pCR) Rate
Objective Response was measured following the Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria. For the purpose of this study a response is defined as the achievement of a complete or partial response measured by breast MRI.
Pathological complete response (pCR) was evaluated following the Symmans method at the time of the definitive surgery. For the purpose of this study RCB-0 was considered a pCR.
The pCR (RCB-0) rate (pCRR) was reported including a 95% confidence interval. The estimate of the pCR rate was calculated as follows by central laboratory:
pCR Rate = Number of patients with pCR / ITT population.
Measured: After surgery, up to 4 months
Objective Response Rate (ORR) by Magnetic Resonance Imaging (MRI)
The ORR was reported including a 95% confidence interval. The estimate of the ORR was determined according to RECIST 1.1 and measured by MRI and mammogram in patients treated with this regimen. ORR was calculated as follows:
Overall Response Rate = Number of Complete Responses (CRs), Partial Responses (PRs) / ITT population
Measured: After surgery, up to 4 months
Objective Response Rate (ORR) by Mammogram
The ORR was reported including a 95% confidence interval. The estimate of the ORR was determined according to RECIST 1.1 and measured by MRI and mammogram in patients treated with this regimen. ORR was calculated as follows:
Overall Response Rate = Number of CRs, PRs / ITT population
Measured: After surgery, up to 4 months
Invasive Disease Free Survival (IDFS)
IDFS was defined as the time (days) from the date of randomization until the date of objective recurrent disease (local, regional or distant), second primary invasive malignancy (breast or non-breast) or death from any cause. For patients not known to have died as of the data cut-off date and who do not have recurrent disease or second primary tumor, invasive disease-free survival will be censored at the last contact date. Ductal carcinoma in-situ (DCIS) will not be considered an event for the purpose of this analysis.
Measured: Up to 6 years
Rate of Conversion to Breast Conserving Surgery (BCS)
The conversion from the initially planned mastectomy to BCS was reported including a 95% confidence interval. The estimate of the rate of conversion to BCS was calculated as follows:
BCS rate = Number of patients with BCS / Number of patients with initially planned mastectomy.
Measured: After surgery, up to 4 months
The Number of Participants Who Experienced Adverse Events (AE)
Incidence of adverse events by maximum CTCAE grade (v4.03; NCI 2010) that occur during the study treatment period or within 30 days of the last dose of study treatment, regardless of causality and according to the relationship to study drug as assessed by the investigator, were collected and evaluated.
Measured: During treatment and until 30 days after the last dose of each patient study treatment
Ki67 in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response
Ki67 was analysed by immunohistochemistry following the American Society of Clinical Oncology and the College of American Pathologists guidelines. The cut-off considered for Ki67 expression was 20% of positively stained tumor cells.
Measured: Baseline visit
Caveolin-1 in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response
Caveolin (Cav)-1 was evaluated in the stroma and its expression was categorized in low, moderate, or high (tertile). The high expression of Cav-1 was considered as positive.
Measured: Baseline visit
Secreted Protein, Acidic, Cysteine-rich (SPARC) in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response
SPARC was evaluated for both tumor and stroma. Its expression was categorized as negative when the intensity was absent-to-weak (1), or moderate (11)-to-strong (111) with a proportion of stained cells <10%. Immunolabeling was positive if the intensity was moderate (11)-to-strong (111) and the extent of staining was 10%.
Measured: Baseline visit
Molecular Tumor Subtypes According to St. Gallen Criteria 2013 in Pre-treatment Tumor Samples as Predictive Marker of Nab-paclitaxel Response
Molecular subtypes were classified according to St. Gallen criteria 2013 and Prat et al. into Luminal A (ER+, Progesterone Receptor (PgR) >20%, Human Epidermal growth factor Receptor 2 - (HER2), Ki67 <14%), Luminal B1 (ER+, HER2-, PgR >20% and/or Ki67 <14%), Luminal B2 (ER+, HER2+, any PgR, any Ki67), TN (ER-, PgR-, HER2-), and HER2-enriched (ER-, PgR-, HER2+) subtypes.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study start17 Apr 2012
- Primary completion1 Jun 2014
- Study completion27 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Breast Cancer Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565499
- Sponsor's protocol ID
- GEICAM/2011-02
- Status last verified
- Mar 2023
- First submitted
- 22 Mar 2012
- Last updated
- 30 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Martin M, Chacon JI, Anton A, Plazaola A, Garcia-Martinez E, Segui MA, Sanchez-Rovira P, Palacios J, Calvo L, Esteban C, Espinosa E, Barnadas A, Batista N, Guerrero A, Munoz M, Romio E, Rodriguez-Martin C, Caballero R, Casas MI, Rojo F, Carrasco E, Antolin S. Neoadjuvant Therapy with Weekly Nanoparticle Albumin-Bound Paclitaxel for Luminal Early Breast Cancer Patients: Results from the NABRAX Study (GEICAM/2011-02), a Multicenter, Non-Randomized, Phase II Trial, with a Companion Biomarker Analysis. Oncologist. 2017 Nov;22(11):1301-1308. doi: 10.1634/theoncologist.2017-0052. Epub 2017 Jul 12.
PubMed 28701571
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open-label, Non-randomized Study of Nab-paclitaxel for the Neoadjuvant Treatment of Patients With Stage II and III Luminal Breast Cancer
- ClinicalTrials.gov ID
- NCT01565499
- Acronym / sponsor ID
- GEICAM/2011-02
- Conditions
- Breast Cancer
- Keywords
- Neoadjuvant nab-paclitaxel luminal breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Spanish Breast Cancer Research GroupUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 17 Apr 2012 (actual)
- Primary completion
- 1 Jun 2014 (actual)
- Study completion
- 27 May 2018 (actual)
- First posted
- 28 Mar 2012 (estimated)
- Results
- Posted 18 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter, open label, non-randomized phase 2 trial to evaluate the efficacy and safety of nab-paclitaxel in the neoadjuvant treatment of ER positive human epidermal growth factor receptor 2 (HER2) negative patients amenable to receive neoadjuvant chemotherapy.
Detailed description
The primary objective of the trial is to determine the percentage of patients with poor response [residual cancer burden III (RCB-III) rate] in contrast to good response [residual cancer burden 0/I RCB-0/1] measured by the Symmans criteria [20] at surgery, in patients with stage II-III luminal breast cancer treated with neoadjuvant nab-paclitaxel.
The primary endpoint of the study is to determine the residual cancer burden grade III (RCB-III) after surgery.
The total number of patients to be included in this study is 78 patients.
The duration of the study, from first patient visit to last patient visit will be approximately 90 months (Including follow-ups)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nab-Paclitaxel | Experimental | Drug: Nab-paclitaxelThe patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female patients with histologically confirmed diagnosis of primary unilateral invasive early breast cancer with longest tumor size in breast ≥ 2cm, or < 2 cm with axillary involvement. In case of a multifocal tumor (tumor foci located in the same quadrant) the largest lesion must be ≥ 2cm (unless axillary involvement) and is designated as the "target" lesion for all subsequent tumor evaluations.
- The breast tumors must be ER positive: more than 1% of stained tumor cells by immuno-histochemistry (IHC), and HER2 negative: 0, or 1+ score by IHC, or 2+ with fluorescence in situ hybridization (FISH)/chromogenic in situ hybridization (CISH) negative for HER2 amplification (defined as a ratio of HER2/neu copies to chromosome 17 centromere (CEP17) signals <1.8), according to the local laboratory).
- Are clear candidates to receive chemotherapy by the investigator criteria.
- Are at least 18 years of age.
- Have at least one unidimensionally measurable lesion by RECIST [65] version 1.1, measured by mammogram.
Key exclusion criteria (11 listed)
- Inflammatory breast cancer (T4d) and supraclavicular lymph nodes (N3)
- Synchronous contralateral or multicentric breast cancer.
- Clinical or radiologic evidence of metastatic disease. Chest examination by x-ray or CT-scan, abdominal examination by CT-scan, bone examination by bone scan as well as other radiological methods in case of suspicion must be performed before enrollment in order to rule out metastasis.
- Second primary malignancy, except adequately treated carcinoma in situ of the cervix, stage I colon cancer, non-invasive melanoma, basal or squamous cell carcinomas of the skin, ipsilateral ductal carcinoma in-situ (DCIS) of the breast and lobular carcinoma in-situ (LCIS) of the breast; unless that prior malignancy was diagnosed and definitively treated more than 5 years ago with no subsequent evidence of recurrence.
- Prior or concurrent anti-cancer therapy for current disease (hormone therapy, chemotherapy, radiotherapy, immunotherapy, biological therapy other than the trial therapies).
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 |
|---|---|---|
| Nab-paclitaxelAlso: Abraxane | Drug | Nab-Paclitaxel |
Primary outcome
The Residual Cancer Burden Grade III (RCB-III).
Time frame: After surgery, up to 4 months
The RCB-III was reported, including a 95% confidence interval. The estimate of the RCB-III was calculated as follows: Overall Response Rate = Number of patients with RCB-III / Intent to treat (ITT) population
10 secondary outcomes
Pathologic Complete Response (pCR) Rate
Time frame: After surgery, up to 4 months
Objective Response Rate (ORR) by Magnetic Resonance Imaging (MRI)
Time frame: After surgery, up to 4 months
Objective Response Rate (ORR) by Mammogram
Time frame: After surgery, up to 4 months
Invasive Disease Free Survival (IDFS)
Time frame: Up to 6 years
Rate of Conversion to Breast Conserving Surgery (BCS)
Time frame: After surgery, up to 4 months
The Number of Participants Who Experienced Adverse Events (AE)
Time frame: During treatment and until 30 days after the last dose of each patient study treatment
Ki67 in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response
Time frame: Baseline visit
Caveolin-1 in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response
Time frame: Baseline visit
Secreted Protein, Acidic, Cysteine-rich (SPARC) in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response
Time frame: Baseline visit
Molecular Tumor Subtypes According to St. Gallen Criteria 2013 in Pre-treatment Tumor Samples as Predictive Marker of Nab-paclitaxel Response
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28701571Martin M, Chacon JI, Anton A, Plazaola A, Garcia-Martinez E, Segui MA, Sanchez-Rovira P, Palacios J, Calvo L, Esteban C, Espinosa E, Barnadas A, Batista N, Guerrero A, Munoz M, Romio E, Rodriguez-Martin C, Caballero R, Casas MI, Rojo F, Carrasco E, Antolin S. Neoadjuvant Therapy with Weekly Nanoparticle Albumin-Bound Paclitaxel for Luminal Early Breast Cancer Patients: Results from the NABRAX Study (GEICAM/2011-02), a Multicenter, Non-Randomized, Phase II Trial, with a Companion Biomarker Analysis. Oncologist. 2017 Nov;22(11):1301-1308. doi: 10.1634/theoncologist.2017-0052. Epub 2017 Jul 12.
- Sponsor's webLink 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.
Study Director study director
Hospital General Universitario Gregorio Marañon
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nab-paclitaxel in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 13 sites in Spain.
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 12 inclusion and 11 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 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain. 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?
Yes. Results are posted in the registry (first posted 18 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Residual Cancer Burden Grade III (RCB-III). (time frame: After surgery, up to 4 months). 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 NCT01565499, 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 30 Mar 2023.