BRCA1 Hereditary Breast and Ovarian Cancer SyndromePhase 2NCT02978495
Neoadjuvant Carboplatin in Triple Negative Breast Cancer
A Phase 2 study testing Doxorubicin, Carboplatin and Paclitaxel in people with BRCA1 Hereditary Breast and Ovarian Cancer Syndrome, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial summary
Breast cancer is the most frequent neoplasm in women in Brazil and in the world and up to 15% of all cases diagnosed correspond to the triple negative subtype. Triple negative breast cancer affects young women with germline mutations in BRCA 1/2 genes. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- BRCA1 Hereditary Breast and Ovarian Cancer Syndrome
- What is being tested?
- Doxorubicin, Carboplatin and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteBrazil
- Study dates
- 17 May 2017to 22 Oct 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Triple Negative Breast Cancer;
- Stage II or III;
- Performance Status ECOG <2 or Karnofsky >50%;
- Hematologic (minimal values):
- Absolute neutrophil count > 1,500/mm3 Hemoglobin > 10.0 g/dl Platelet count > 100,000/mm3
Who cannot join
- Stage I or IV;
- other malignancies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Carboplatin in Triple Negative Breast Cancer - A Prospective Phase II Study (NACATRINE Trial).
Breast cancer is the most frequent neoplasm in women in Brazil and in the world and up to 15% of all cases diagnosed correspond to the triple negative subtype. Triple negative breast cancer affects young women with germline mutations in BRCA 1/2 genes. Giving the lack of target therapies to date, there is no consensus regarding the most effective treatment for this subgroup of tumors. Although evidence shows that triple negative breast cancer is highly sensitive to chemotherapy when compared to other breast tumors, there is no evidence to support the hypothesis that patients with triple negative breast cancer and mutation in BRCA1 / 2 genes have higher chemosensitivity to neoadjuvant therapy. The investigator proposes a prospective, randomized, open-label, phase II study, evaluating the rate of complete pathologic response, disease-free survival, overall survival and prognostic evaluation of BRCA1 / 2 mutation status in women with triple negative breast cancer submitted to sequential neoadjuvant chemotherapy based on anthracycline and taxane, with or without carboplatin.
- Being tested
- Doxorubicin, Carboplatin, Paclitaxel, Cyclophosphamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
Doxorrubicin 60 mg/m2 4 cycles each 21 days
CarboplatinDrug
Carboplatin AUC 1,5 once a week, for 12 weeks
PaclitaxelDrug
80mg/m2 weekly for 12 weeks
CyclophosphamideDrug
600mg/m2 4 cycles each 21 days
| Study group | Role | What they receive |
|---|---|---|
| A- BRCA Mutation | Experimental | 1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:
2. Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks. Receives: Drug: Doxorubicin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Cyclophosphamide |
| B- BRCA Mutation | Active comparator | 1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:
2. Paclitaxel 80 mg/m2 once a week, for 12 weeks. Receives: Drug: Doxorubicin; Drug: Paclitaxel; Drug: Cyclophosphamide |
| C- BRCA wild-type | Experimental | 1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:
2. Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks. Receives: Drug: Doxorubicin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Cyclophosphamide |
| D- BRCA wild-type | Active comparator | 1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:
2. Paclitaxel 80 mg/m2 once a week, for 12 weeks. Receives: Drug: Doxorubicin; Drug: Paclitaxel; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR), defined as absence of invasive cancer in the breast and axillary lymph nodes.
Measured: within the first 21 days after surgery
Secondary outcomes (2)
Disease free survival (DFS)
Measured: within the first 60 month after surgery
Overall survival (OS)
Measured: within the first 60 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study start17 May 2017
- Primary completion2 Dec 2019
- Study completion22 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for BRCA1 Hereditary Breast and Ovarian Cancer SyndromeStudies 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
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiano de Padua, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978495
- Sponsor's protocol ID
- BarretosCH - 20162
- Status last verified
- Dec 2022
- First submitted
- 24 Nov 2016
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
von Minckwitz G, Schneeweiss A, Loibl S, Salat C, Denkert C, Rezai M, Blohmer JU, Jackisch C, Paepke S, Gerber B, Zahm DM, Kummel S, Eidtmann H, Klare P, Huober J, Costa S, Tesch H, Hanusch C, Hilfrich J, Khandan F, Fasching PA, Sinn BV, Engels K, Mehta K, Nekljudova V, Untch M. Neoadjuvant carboplatin in patients with triple-negative and HER2-positive early breast cancer (GeparSixto; GBG 66): a randomised phase 2 trial. Lancet Oncol. 2014 Jun;15(7):747-56. doi: 10.1016/S1470-2045(14)70160-3. Epub 2014 Apr 30.
PubMed 24794243Gerber B, Loibl S, Eidtmann H, Rezai M, Fasching PA, Tesch H, Eggemann H, Schrader I, Kittel K, Hanusch C, Kreienberg R, Solbach C, Jackisch C, Kunz G, Blohmer JU, Huober J, Hauschild M, Nekljudova V, Untch M, von Minckwitz G; German Breast Group Investigators. Neoadjuvant bevacizumab and anthracycline-taxane-based chemotherapy in 678 triple-negative primary breast cancers; results from the geparquinto study (GBG 44). Ann Oncol. 2013 Dec;24(12):2978-84. doi: 10.1093/annonc/mdt361. Epub 2013 Oct 17.
PubMed 24136883Byrski T, Gronwald J, Huzarski T, Grzybowska E, Budryk M, Stawicka M, Mierzwa T, Szwiec M, Wisniowski R, Siolek M, Dent R, Lubinski J, Narod S. Pathologic complete response rates in young women with BRCA1-positive breast cancers after neoadjuvant chemotherapy. J Clin Oncol. 2010 Jan 20;28(3):375-9. doi: 10.1200/JCO.2008.20.7019. Epub 2009 Dec 14.
PubMed 20008645Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance). J Clin Oncol. 2015 Jan 1;33(1):13-21. doi: 10.1200/JCO.2014.57.0572. Epub 2014 Aug 4.
PubMed 25092775Valsecchi ME, Kimmey G, Bir A, Silbermins D. Role of Carboplatin in the Treatment of Triple Negative Early- Stage Breast Cancer. Rev Recent Clin Trials. 2015;10(2):101-10. doi: 10.2174/1574887110666150624101343.
PubMed 26104428Arun B, Bayraktar S, Liu DD, Gutierrez Barrera AM, Atchley D, Pusztai L, Litton JK, Valero V, Meric-Bernstam F, Hortobagyi GN, Albarracin C. Response to neoadjuvant systemic therapy for breast cancer in BRCA mutation carriers and noncarriers: a single-institution experience. J Clin Oncol. 2011 Oct 1;29(28):3739-46. doi: 10.1200/JCO.2011.35.2682. Epub 2011 Sep 6.
PubMed 21900106Gonzalez-Angulo AM, Timms KM, Liu S, Chen H, Litton JK, Potter J, Lanchbury JS, Stemke-Hale K, Hennessy BT, Arun BK, Hortobagyi GN, Do KA, Mills GB, Meric-Bernstam F. Incidence and outcome of BRCA mutations in unselected patients with triple receptor-negative breast cancer. Clin Cancer Res. 2011 Mar 1;17(5):1082-9. doi: 10.1158/1078-0432.CCR-10-2560. Epub 2011 Jan 13.
PubMed 21233401Paluch-Shimon S, Friedman E, Berger R, Papa M, Dadiani M, Friedman N, Shabtai M, Zippel D, Gutman M, Golan T, Yosepovich A, Catane R, Modiano T, Kaufman B. Neo-adjuvant doxorubicin and cyclophosphamide followed by paclitaxel in triple-negative breast cancer among BRCA1 mutation carriers and non-carriers. Breast Cancer Res Treat. 2016 May;157(1):157-65. doi: 10.1007/s10549-016-3800-5. Epub 2016 Apr 25.
PubMed 27113739Muendlein A, Rohde BH, Gasser K, Haid A, Rauch S, Kinz E, Drexel H, Hofmann W, Schindler V, Kapoor R, Decker T, Lang AH. Evaluation of BRCA1/2 mutational status among German and Austrian women with triple-negative breast cancer. J Cancer Res Clin Oncol. 2015 Nov;141(11):2005-12. doi: 10.1007/s00432-015-1986-2. Epub 2015 May 15.
PubMed 25971625
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Carboplatin in Triple Negative Breast Cancer - A Prospective Phase II Study (NACATRINE Trial).
- ClinicalTrials.gov ID
- NCT02978495
- Acronym / sponsor ID
- BarretosCH - 20162
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- 17 May 2017 (actual)
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 22 Oct 2021 (actual)
- First posted
- 1 Dec 2016 (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.
Breast cancer is the most frequent neoplasm in women in Brazil and in the world and up to 15% of all cases diagnosed correspond to the triple negative subtype. Triple negative breast cancer affects young women with germline mutations in BRCA 1/2 genes. Giving the lack of target therapies to date, there is no consensus regarding the most effective treatment for this subgroup of tumors. Although evidence shows that triple negative breast cancer is highly sensitive to chemotherapy when compared to other breast tumors, there is no evidence to support the hypothesis that patients with triple negative breast cancer and mutation in BRCA1 / 2 genes have higher chemosensitivity to neoadjuvant therapy. The investigator proposes a prospective, randomized, open-label, phase II study, evaluating the rate of complete pathologic response, disease-free survival, overall survival and prognostic evaluation of BRCA1 / 2 mutation status in women with triple negative breast cancer submitted to sequential neoadjuvant chemotherapy based on anthracycline and taxane, with or without carboplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A- BRCA Mutation | Experimental | Drug: Doxorubicin, Drug: Carboplatin, Drug: Paclitaxel, Drug: Cyclophosphamide1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks. |
| B- BRCA Mutation | Active comparator | Drug: Doxorubicin, Drug: Paclitaxel, Drug: Cyclophosphamide1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks. |
| C- BRCA wild-type | Experimental | Drug: Doxorubicin, Drug: Carboplatin, Drug: Paclitaxel, Drug: Cyclophosphamide1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks. |
| D- BRCA wild-type | Active comparator | Drug: Doxorubicin, Drug: Paclitaxel, Drug: Cyclophosphamide1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Triple Negative Breast Cancer;
- Stage II or III;
- Performance Status ECOG <2 or Karnofsky >50%;
- Hematologic (minimal values):
- Absolute neutrophil count > 1,500/mm3 Hemoglobin > 10.0 g/dl Platelet count > 100,000/mm3
Key exclusion criteria (2 listed)
- Stage I or IV;
- other malignancies.
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 |
|---|---|---|
| DoxorubicinDoxorrubicin 60 mg/m2 4 cycles each 21 days | Drug | A- BRCA Mutation, B- BRCA Mutation, C- BRCA wild-type, D- BRCA wild-type |
| CarboplatinCarboplatin AUC 1,5 once a week, for 12 weeks | Drug | A- BRCA Mutation, C- BRCA wild-type |
| Paclitaxel80mg/m2 weekly for 12 weeks | Drug | A- BRCA Mutation, B- BRCA Mutation, C- BRCA wild-type, D- BRCA wild-type |
| Cyclophosphamide600mg/m2 4 cycles each 21 days | Drug | A- BRCA Mutation, B- BRCA Mutation, C- BRCA wild-type, D- BRCA wild-type |
Primary outcome
Pathological complete response (pCR), defined as absence of invasive cancer in the breast and axillary lymph nodes.
Time frame: within the first 21 days after surgery
2 secondary outcomes
Disease free survival (DFS)
Time frame: within the first 60 month after surgery
Overall survival (OS)
Time frame: within the first 60 month after 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 28 Dec 2022.
- Results publication: PubMed 24794243von Minckwitz G, Schneeweiss A, Loibl S, Salat C, Denkert C, Rezai M, Blohmer JU, Jackisch C, Paepke S, Gerber B, Zahm DM, Kummel S, Eidtmann H, Klare P, Huober J, Costa S, Tesch H, Hanusch C, Hilfrich J, Khandan F, Fasching PA, Sinn BV, Engels K, Mehta K, Nekljudova V, Untch M. Neoadjuvant carboplatin in patients with triple-negative and HER2-positive early breast cancer (GeparSixto; GBG 66): a randomised phase 2 trial. Lancet Oncol. 2014 Jun;15(7):747-56. doi: 10.1016/S1470-2045(14)70160-3. Epub 2014 Apr 30.
- Results publication: PubMed 24136883Gerber B, Loibl S, Eidtmann H, Rezai M, Fasching PA, Tesch H, Eggemann H, Schrader I, Kittel K, Hanusch C, Kreienberg R, Solbach C, Jackisch C, Kunz G, Blohmer JU, Huober J, Hauschild M, Nekljudova V, Untch M, von Minckwitz G; German Breast Group Investigators. Neoadjuvant bevacizumab and anthracycline-taxane-based chemotherapy in 678 triple-negative primary breast cancers; results from the geparquinto study (GBG 44). Ann Oncol. 2013 Dec;24(12):2978-84. doi: 10.1093/annonc/mdt361. Epub 2013 Oct 17.
- Results publication: PubMed 20008645Byrski T, Gronwald J, Huzarski T, Grzybowska E, Budryk M, Stawicka M, Mierzwa T, Szwiec M, Wisniowski R, Siolek M, Dent R, Lubinski J, Narod S. Pathologic complete response rates in young women with BRCA1-positive breast cancers after neoadjuvant chemotherapy. J Clin Oncol. 2010 Jan 20;28(3):375-9. doi: 10.1200/JCO.2008.20.7019. Epub 2009 Dec 14.
- Results publication: PubMed 25092775Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance). J Clin Oncol. 2015 Jan 1;33(1):13-21. doi: 10.1200/JCO.2014.57.0572. Epub 2014 Aug 4.
- Results publication: PubMed 26104428Valsecchi ME, Kimmey G, Bir A, Silbermins D. Role of Carboplatin in the Treatment of Triple Negative Early- Stage Breast Cancer. Rev Recent Clin Trials. 2015;10(2):101-10. doi: 10.2174/1574887110666150624101343.
- Results publication: PubMed 21900106Arun B, Bayraktar S, Liu DD, Gutierrez Barrera AM, Atchley D, Pusztai L, Litton JK, Valero V, Meric-Bernstam F, Hortobagyi GN, Albarracin C. Response to neoadjuvant systemic therapy for breast cancer in BRCA mutation carriers and noncarriers: a single-institution experience. J Clin Oncol. 2011 Oct 1;29(28):3739-46. doi: 10.1200/JCO.2011.35.2682. Epub 2011 Sep 6.
- Results publication: PubMed 21233401Gonzalez-Angulo AM, Timms KM, Liu S, Chen H, Litton JK, Potter J, Lanchbury JS, Stemke-Hale K, Hennessy BT, Arun BK, Hortobagyi GN, Do KA, Mills GB, Meric-Bernstam F. Incidence and outcome of BRCA mutations in unselected patients with triple receptor-negative breast cancer. Clin Cancer Res. 2011 Mar 1;17(5):1082-9. doi: 10.1158/1078-0432.CCR-10-2560. Epub 2011 Jan 13.
- Results publication: PubMed 27113739Paluch-Shimon S, Friedman E, Berger R, Papa M, Dadiani M, Friedman N, Shabtai M, Zippel D, Gutman M, Golan T, Yosepovich A, Catane R, Modiano T, Kaufman B. Neo-adjuvant doxorubicin and cyclophosphamide followed by paclitaxel in triple-negative breast cancer among BRCA1 mutation carriers and non-carriers. Breast Cancer Res Treat. 2016 May;157(1):157-65. doi: 10.1007/s10549-016-3800-5. Epub 2016 Apr 25.
- Results publication: PubMed 25971625Muendlein A, Rohde BH, Gasser K, Haid A, Rauch S, Kinz E, Drexel H, Hofmann W, Schindler V, Kapoor R, Decker T, Lang AH. Evaluation of BRCA1/2 mutational status among German and Austrian women with triple-negative breast cancer. J Cancer Res Clin Oncol. 2015 Nov;141(11):2005-12. doi: 10.1007/s00432-015-1986-2. Epub 2015 May 15.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxorubicin, Carboplatin and Paclitaxel in people with BRCA1 Hereditary Breast and Ovarian Cancer Syndrome, run by Barretos Cancer Hospital at 1 site in Brazil.
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 5 inclusion and 2 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 28 Dec 2022. 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 Brazil. 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), defined as absence of invasive cancer in the breast and axillary lymph nodes. (time frame: within the first 21 days after 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 NCT02978495, which also lists 9 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 28 Dec 2022.