HER2+ Breast CancerNCT05931042
Neoadjuvant Therapy With Trastuzumab and Chemotherapy and the Resultant Pathologic Complete Response Observed in HER2 Positive Breast Cancer;a Systematic Review
An observational study of HER2+ Breast Cancer, run by Rawalpindi Medical College at 1 site in Pakistan.
Trial summary
The goal of this systematic review is to assess the effectiveness of neoadjuvant chemotherapy and Trastuzumab in achieving pathological complete response (pCR) in patients with HER2-positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2+ Breast Cancer
- What is being tested?
- Trastuzumab
- How many people
- 1,209 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2023to 18 Jun 2023
- Phase
- Observational
- 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
Study population: This study only included clinical trials. The review methods were decided before the start of the review. Studies that used the pathological complete response (pCR) as their primary or secondary endpoint were considered. The proportion of patients without invasive breast and axillary cancer was the criteria used to define pCR (ypT0/is and ypN0). Patients with breast cancer that was found to be HER2 positive were included. If the HER2 FISH test score was 2 or higher or the immunohistochemistry score for HER2 was +3, the HER2 status was interpreted as positive.
Who may be able to join
- Patients with breast cancer that was found to be HER2 positive were included
- Only patients who underwent neoadjuvant therapy were included
- All cytotoxic chemotherapy regimens were considered eligible for this systematic review given that the same drugs were given at the same dose in every trial.
Who cannot join
- Patients with metastatic breast cancer were not included in the systematic review
- Results from adjuvant therapy were excluded from this study.
- Only the most recent publication (and the most informative) was included if numerous publications of the same trial were retrieved or if there was a case mix between publications.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rawalpindi Medical University
Rawalpindi, Punjab Province, 46000
About this study
The goal of this systematic review is to assess the effectiveness of neoadjuvant chemotherapy and Trastuzumab in achieving pathological complete response (pCR) in patients with HER2-positive breast cancer. The main questions it aims to answer are:
- What is the overall rate of pathological complete response (pCR) in HER2-positive breast cancer patients treated with neoadjuvant chemotherapy and Trastuzumab?
- Are there any variations in the definition of pCR among the included trials?
Read more
Participants in the selected clinical trials were HER2-positive breast cancer patients with non-metastatic operable, locally advanced, or inflammatory breast cancer. The main tasks participants were asked to do and the treatments they received are as follows:
- Undergo neoadjuvant chemotherapy: Participants received chemotherapy treatment before their primary surgery.
- Receive Trastuzumab: Participants were administered Trastuzumab, a targeted therapy for HER2-positive breast cancer.
Researchers would compare the group of participants receiving neoadjuvant chemotherapy and Trastuzumab to other groups, if present, to see if there are differences in the rates of pathological complete response (pCR) or other effects.
Read the detailed description
This systematic review aimed to assess the effectiveness of neoadjuvant chemotherapy and Trastuzumab in achieving pathological complete response (pCR) in patients with HER2-positive breast cancer. The researchers identified nine clinical trials that met the inclusion criteria. These trials included patients with non-metastatic operable, locally advanced, or inflammatory breast cancer, and they evaluated the pCR as the primary or secondary endpoint.
The trials utilized different chemotherapy and targeted therapy regimens, along with varying dosages of Trastuzumab. The primary outcome of interest was the pCR rate, while other survival outcomes were not analyzed. Among the 1,209 patients who received neoadjuvant chemotherapy and Trastuzumab, the overall pCR rate was found to be 42%.
The review provided detailed information about the design of the selected trials, patient characteristics, disease staging, HER2 status, administered treatment regimens, and primary/secondary endpoints. It also mentioned slight variations in the definition of pCR across the trials.
- Conditions
- HER2+ Breast Cancer
- Being tested
- Trastuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Trastuzumab was given at dosage of either 4mg/kg or 8mg/kg at mostly a weekly interval (but differs among the different studies)
| Study group | Role | What they receive |
|---|---|---|
| Group recieving Trastuzumab + Chemotherapy | Two different treatment regimens of Trastuzumab were giving in the 9 studies Dosage of trastuzumab was 4 mg/kg loading dose followed by 2 mg/kg every 3 weeks in four clinical trials included in this systematic review Dosage of trastuzumab was 8 mg/kg loading dose, followed by 6 mg/kg every 3 weeks in five clinical trials included in this systematic review The different chemotherapeutic agents given included Paclitaxel, docetaxel, fluorouracil, epirubicin, carboplatin, cyclophosphamide, methotrexate, and fluorouracil. Receives: Drug: Trastuzumab | |
| Group receiving chemotherapy | Different neoadjuvant chemotherapy regimens were given in the nine clinical trials included in this systematic review. The different chemotherapeutic agents given included Paclitaxel, docetaxel, fluorouracil, epirubicin, carboplatin, cyclophosphamide, methotrexate, and fluorouracil. Receives: Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
5 trials labelled pCR as the absence of residual invasive cancer in the breast and lymph nodes while 4 trials defined pCR as the absence of invasive neoplastic cells at microscopic examination of the primary tumour at surgery
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Jun 2023
- Primary completion15 Jun 2023
- Study completion18 Jun 2023
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 HER2+ 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maham Leeza Adil, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931042
- Sponsor's protocol ID
- 823678
- Status last verified
- Jun 2023
- First submitted
- 26 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No patient data to be shared
Publications
I-SPY2 Trial Consortium; Yee D, DeMichele AM, Yau C, Isaacs C, Symmans WF, Albain KS, Chen YY, Krings G, Wei S, Harada S, Datnow B, Fadare O, Klein M, Pambuccian S, Chen B, Adamson K, Sams S, Mhawech-Fauceglia P, Magliocco A, Feldman M, Rendi M, Sattar H, Zeck J, Ocal IT, Tawfik O, LeBeau LG, Sahoo S, Vinh T, Chien AJ, Forero-Torres A, Stringer-Reasor E, Wallace AM, Pusztai L, Boughey JC, Ellis ED, Elias AD, Lu J, Lang JE, Han HS, Clark AS, Nanda R, Northfelt DW, Khan QJ, Viscusi RK, Euhus DM, Edmiston KK, Chui SY, Kemmer K, Park JW, Liu MC, Olopade O, Leyland-Jones B, Tripathy D, Moulder SL, Rugo HS, Schwab R, Lo S, Helsten T, Beckwith H, Haugen P, Hylton NM, Van't Veer LJ, Perlmutter J, Melisko ME, Wilson A, Peterson G, Asare AL, Buxton MB, Paoloni M, Clennell JL, Hirst GL, Singhrao R, Steeg K, Matthews JB, Asare SM, Sanil A, Berry SM, Esserman LJ, Berry DA. Association of Event-Free and Distant Recurrence-Free Survival With Individual-Level Pathologic Complete Response in Neoadjuvant Treatment of Stages 2 and 3 Breast Cancer: Three-Year Follow-up Analysis for the I-SPY2 Adaptively Randomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1355-1362. doi: 10.1001/jamaoncol.2020.2535.
PubMed 32701140Ismael G, Hegg R, Muehlbauer S, Heinzmann D, Lum B, Kim SB, Pienkowski T, Lichinitser M, Semiglazov V, Melichar B, Jackisch C. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol. 2012 Sep;13(9):869-78. doi: 10.1016/S1470-2045(12)70329-7. Epub 2012 Aug 9.
PubMed 22884505Buzdar AU, Ibrahim NK, Francis D, Booser DJ, Thomas ES, Theriault RL, Pusztai L, Green MC, Arun BK, Giordano SH, Cristofanilli M, Frye DK, Smith TL, Hunt KK, Singletary SE, Sahin AA, Ewer MS, Buchholz TA, Berry D, Hortobagyi GN. Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy: results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer. J Clin Oncol. 2005 Jun 1;23(16):3676-85. doi: 10.1200/JCO.2005.07.032. Epub 2005 Feb 28.
PubMed 15738535Buzdar AU, Suman VJ, Meric-Bernstam F, Leitch AM, Ellis MJ, Boughey JC, Unzeitig G, Royce M, McCall LM, Ewer MS, Hunt KK; American College of Surgeons Oncology Group investigators. Fluorouracil, epirubicin, and cyclophosphamide (FEC-75) followed by paclitaxel plus trastuzumab versus paclitaxel plus trastuzumab followed by FEC-75 plus trastuzumab as neoadjuvant treatment for patients with HER2-positive breast cancer (Z1041): a randomised, controlled, phase 3 trial. Lancet Oncol. 2013 Dec;14(13):1317-25. doi: 10.1016/S1470-2045(13)70502-3. Epub 2013 Nov 13.
PubMed 24239210Semiglazov V, Eiermann W, Zambetti M, Manikhas A, Bozhok A, Lluch A, Tjulandin S, Sabadell MD, Caballero A, Valagussa P, Baselga J, Gianni L. Surgery following neoadjuvant therapy in patients with HER2-positive locally advanced or inflammatory breast cancer participating in the NeOAdjuvant Herceptin (NOAH) study. Eur J Surg Oncol. 2011 Oct;37(10):856-63. doi: 10.1016/j.ejso.2011.07.003. Epub 2011 Aug 16.
PubMed 21843921van Ramshorst MS, van Werkhoven E, Mandjes IAM, Schot M, Wesseling J, Vrancken Peeters MTFD, Meerum Terwogt JM, Bos MEM, Oosterkamp HM, Rodenhuis S, Linn SC, Sonke GS. Trastuzumab in combination with weekly paclitaxel and carboplatin as neo-adjuvant treatment for HER2-positive breast cancer: The TRAIN-study. Eur J Cancer. 2017 Mar;74:47-54. doi: 10.1016/j.ejca.2016.12.023. Epub 2017 Feb 10.
PubMed 28335887Gianni L, Pienkowski T, Im YH, Roman L, Tseng LM, Liu MC, Lluch A, Staroslawska E, de la Haba-Rodriguez J, Im SA, Pedrini JL, Poirier B, Morandi P, Semiglazov V, Srimuninnimit V, Bianchi G, Szado T, Ratnayake J, Ross G, Valagussa P. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012 Jan;13(1):25-32. doi: 10.1016/S1470-2045(11)70336-9. Epub 2011 Dec 6.
PubMed 22153890Shao Z, Pang D, Yang H, Li W, Wang S, Cui S, Liao N, Wang Y, Wang C, Chang YC, Wang H, Kang SY, Seo JH, Shen K, Laohawiriyakamol S, Jiang Z, Li J, Zhou J, Althaus B, Mao Y, Eng-Wong J. Efficacy, Safety, and Tolerability of Pertuzumab, Trastuzumab, and Docetaxel for Patients With Early or Locally Advanced ERBB2-Positive Breast Cancer in Asia: The PEONY Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Mar 1;6(3):e193692. doi: 10.1001/jamaoncol.2019.3692. Epub 2020 Mar 12.
PubMed 31647503Beitsch P, Whitworth P, Baron P, Rotkis MC, Mislowsky AM, Richards PD, Murray MK, Pellicane JV, Dul CL, Nash CH, Stork-Sloots L, de Snoo F, Untch S, Lee LA. Pertuzumab/Trastuzumab/CT Versus Trastuzumab/CT Therapy for HER2+ Breast Cancer: Results from the Prospective Neoadjuvant Breast Registry Symphony Trial (NBRST). Ann Surg Oncol. 2017 Sep;24(9):2539-2546. doi: 10.1245/s10434-017-5863-x. Epub 2017 Apr 26.
PubMed 28447218
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Therapy With Trastuzumab and Chemotherapy and the Resultant Pathologic Complete Response Observed in HER2 Positive Breast Cancer;a Systematic Review
- ClinicalTrials.gov ID
- NCT05931042
- Acronym / sponsor ID
- 823678
- Conditions
- HER2+ Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,209 participants (actual)
- Lead sponsor
- Rawalpindi Medical CollegeUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 18 Jun 2023 (actual)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this systematic review is to assess the effectiveness of neoadjuvant chemotherapy and Trastuzumab in achieving pathological complete response (pCR) in patients with HER2-positive breast cancer. The main questions it aims to answer are:
- What is the overall rate of pathological complete response (pCR) in HER2-positive breast cancer patients treated with neoadjuvant chemotherapy and Trastuzumab?
- Are there any variations in the definition of pCR among the included trials?
Participants in the selected clinical trials were HER2-positive breast cancer patients with non-metastatic operable, locally advanced, or inflammatory breast cancer. The main tasks participants were asked to do and the treatments they received are as follows:
- Undergo neoadjuvant chemotherapy: Participants received chemotherapy treatment before their primary surgery.
- Receive Trastuzumab: Participants were administered Trastuzumab, a targeted therapy for HER2-positive breast cancer.
Researchers would compare the group of participants receiving neoadjuvant chemotherapy and Trastuzumab to other groups, if present, to see if there are differences in the rates of pathological complete response (pCR) or other effects.
Detailed description
This systematic review aimed to assess the effectiveness of neoadjuvant chemotherapy and Trastuzumab in achieving pathological complete response (pCR) in patients with HER2-positive breast cancer. The researchers identified nine clinical trials that met the inclusion criteria. These trials included patients with non-metastatic operable, locally advanced, or inflammatory breast cancer, and they evaluated the pCR as the primary or secondary endpoint.
The trials utilized different chemotherapy and targeted therapy regimens, along with varying dosages of Trastuzumab. The primary outcome of interest was the pCR rate, while other survival outcomes were not analyzed. Among the 1,209 patients who received neoadjuvant chemotherapy and Trastuzumab, the overall pCR rate was found to be 42%.
The review provided detailed information about the design of the selected trials, patient characteristics, disease staging, HER2 status, administered treatment regimens, and primary/secondary endpoints. It also mentioned slight variations in the definition of pCR across the trials.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group recieving Trastuzumab + Chemotherapy | – | Drug: TrastuzumabTwo different treatment regimens of Trastuzumab were giving in the 9 studies Dosage of trastuzumab was 4 mg/kg loading dose followed by 2 mg/kg every 3 weeks in four clinical trials included in this systematic review Dosage of trastuzumab was 8 mg/kg loading dose, followed by 6 mg/kg every 3 weeks in five clinical trials included in this systematic review The different chemotherapeutic agents given included Paclitaxel, docetaxel, fluorouracil, epirubicin, carboplatin, cyclophosphamide, methotrexate, and fluorouracil. |
| Group receiving chemotherapy | – | Drug: TrastuzumabDifferent neoadjuvant chemotherapy regimens were given in the nine clinical trials included in this systematic review. The different chemotherapeutic agents given included Paclitaxel, docetaxel, fluorouracil, epirubicin, carboplatin, cyclophosphamide, methotrexate, and fluorouracil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study only included clinical trials. The review methods were decided before the start of the review. Studies that used the pathological complete response (pCR) as their primary or secondary endpoint were considered. The proportion of patients without invasive breast and axillary cancer was the criteria used to define pCR (ypT0/is and ypN0). Patients with breast cancer that was found to be HER2 positive were included. If the HER2 FISH test score was 2 or higher or the immunohistochemistry score for HER2 was +3, the HER2 status was interpreted as positive.
Key inclusion criteria (3 listed)
- Patients with breast cancer that was found to be HER2 positive were included
- Only patients who underwent neoadjuvant therapy were included
- All cytotoxic chemotherapy regimens were considered eligible for this systematic review given that the same drugs were given at the same dose in every trial.
Key exclusion criteria (3 listed)
- Patients with metastatic breast cancer were not included in the systematic review
- Results from adjuvant therapy were excluded from this study.
- Only the most recent publication (and the most informative) was included if numerous publications of the same trial were retrieved or if there was a case mix between publications.
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 |
|---|---|---|
| TrastuzumabTrastuzumab was given at dosage of either 4mg/kg or 8mg/kg at mostly a weekly interval (but differs among the different studies) | Drug | Group receiving chemotherapy, Group recieving Trastuzumab + Chemotherapy |
Primary outcome
Pathological Complete Response (pCR)
Time frame: 5 years
5 trials labelled pCR as the absence of residual invasive cancer in the breast and lymph nodes while 4 trials defined pCR as the absence of invasive neoplastic cells at microscopic examination of the primary tumour at 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 5 Jul 2023.
- Background: PubMed 32701140I-SPY2 Trial Consortium; Yee D, DeMichele AM, Yau C, Isaacs C, Symmans WF, Albain KS, Chen YY, Krings G, Wei S, Harada S, Datnow B, Fadare O, Klein M, Pambuccian S, Chen B, Adamson K, Sams S, Mhawech-Fauceglia P, Magliocco A, Feldman M, Rendi M, Sattar H, Zeck J, Ocal IT, Tawfik O, LeBeau LG, Sahoo S, Vinh T, Chien AJ, Forero-Torres A, Stringer-Reasor E, Wallace AM, Pusztai L, Boughey JC, Ellis ED, Elias AD, Lu J, Lang JE, Han HS, Clark AS, Nanda R, Northfelt DW, Khan QJ, Viscusi RK, Euhus DM, Edmiston KK, Chui SY, Kemmer K, Park JW, Liu MC, Olopade O, Leyland-Jones B, Tripathy D, Moulder SL, Rugo HS, Schwab R, Lo S, Helsten T, Beckwith H, Haugen P, Hylton NM, Van't Veer LJ, Perlmutter J, Melisko ME, Wilson A, Peterson G, Asare AL, Buxton MB, Paoloni M, Clennell JL, Hirst GL, Singhrao R, Steeg K, Matthews JB, Asare SM, Sanil A, Berry SM, Esserman LJ, Berry DA. Association of Event-Free and Distant Recurrence-Free Survival With Individual-Level Pathologic Complete Response in Neoadjuvant Treatment of Stages 2 and 3 Breast Cancer: Three-Year Follow-up Analysis for the I-SPY2 Adaptively Randomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1355-1362. doi: 10.1001/jamaoncol.2020.2535.
- Background: PubMed 22884505Ismael G, Hegg R, Muehlbauer S, Heinzmann D, Lum B, Kim SB, Pienkowski T, Lichinitser M, Semiglazov V, Melichar B, Jackisch C. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol. 2012 Sep;13(9):869-78. doi: 10.1016/S1470-2045(12)70329-7. Epub 2012 Aug 9.
- Background: PubMed 15738535Buzdar AU, Ibrahim NK, Francis D, Booser DJ, Thomas ES, Theriault RL, Pusztai L, Green MC, Arun BK, Giordano SH, Cristofanilli M, Frye DK, Smith TL, Hunt KK, Singletary SE, Sahin AA, Ewer MS, Buchholz TA, Berry D, Hortobagyi GN. Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy: results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer. J Clin Oncol. 2005 Jun 1;23(16):3676-85. doi: 10.1200/JCO.2005.07.032. Epub 2005 Feb 28.
- Background: PubMed 24239210Buzdar AU, Suman VJ, Meric-Bernstam F, Leitch AM, Ellis MJ, Boughey JC, Unzeitig G, Royce M, McCall LM, Ewer MS, Hunt KK; American College of Surgeons Oncology Group investigators. Fluorouracil, epirubicin, and cyclophosphamide (FEC-75) followed by paclitaxel plus trastuzumab versus paclitaxel plus trastuzumab followed by FEC-75 plus trastuzumab as neoadjuvant treatment for patients with HER2-positive breast cancer (Z1041): a randomised, controlled, phase 3 trial. Lancet Oncol. 2013 Dec;14(13):1317-25. doi: 10.1016/S1470-2045(13)70502-3. Epub 2013 Nov 13.
- Background: PubMed 21843921Semiglazov V, Eiermann W, Zambetti M, Manikhas A, Bozhok A, Lluch A, Tjulandin S, Sabadell MD, Caballero A, Valagussa P, Baselga J, Gianni L. Surgery following neoadjuvant therapy in patients with HER2-positive locally advanced or inflammatory breast cancer participating in the NeOAdjuvant Herceptin (NOAH) study. Eur J Surg Oncol. 2011 Oct;37(10):856-63. doi: 10.1016/j.ejso.2011.07.003. Epub 2011 Aug 16.
- Background: PubMed 28335887van Ramshorst MS, van Werkhoven E, Mandjes IAM, Schot M, Wesseling J, Vrancken Peeters MTFD, Meerum Terwogt JM, Bos MEM, Oosterkamp HM, Rodenhuis S, Linn SC, Sonke GS. Trastuzumab in combination with weekly paclitaxel and carboplatin as neo-adjuvant treatment for HER2-positive breast cancer: The TRAIN-study. Eur J Cancer. 2017 Mar;74:47-54. doi: 10.1016/j.ejca.2016.12.023. Epub 2017 Feb 10.
- Background: PubMed 22153890Gianni L, Pienkowski T, Im YH, Roman L, Tseng LM, Liu MC, Lluch A, Staroslawska E, de la Haba-Rodriguez J, Im SA, Pedrini JL, Poirier B, Morandi P, Semiglazov V, Srimuninnimit V, Bianchi G, Szado T, Ratnayake J, Ross G, Valagussa P. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012 Jan;13(1):25-32. doi: 10.1016/S1470-2045(11)70336-9. Epub 2011 Dec 6.
- Background: PubMed 31647503Shao Z, Pang D, Yang H, Li W, Wang S, Cui S, Liao N, Wang Y, Wang C, Chang YC, Wang H, Kang SY, Seo JH, Shen K, Laohawiriyakamol S, Jiang Z, Li J, Zhou J, Althaus B, Mao Y, Eng-Wong J. Efficacy, Safety, and Tolerability of Pertuzumab, Trastuzumab, and Docetaxel for Patients With Early or Locally Advanced ERBB2-Positive Breast Cancer in Asia: The PEONY Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Mar 1;6(3):e193692. doi: 10.1001/jamaoncol.2019.3692. Epub 2020 Mar 12.
- Background: PubMed 28447218Beitsch P, Whitworth P, Baron P, Rotkis MC, Mislowsky AM, Richards PD, Murray MK, Pellicane JV, Dul CL, Nash CH, Stork-Sloots L, de Snoo F, Untch S, Lee LA. Pertuzumab/Trastuzumab/CT Versus Trastuzumab/CT Therapy for HER2+ Breast Cancer: Results from the Prospective Neoadjuvant Breast Registry Symphony Trial (NBRST). Ann Surg Oncol. 2017 Sep;24(9):2539-2546. doi: 10.1245/s10434-017-5863-x. Epub 2017 Apr 26.
- Individual participant dataSharing planned: No. No patient data to be shared
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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?
An observational study of HER2+ Breast Cancer, run by Rawalpindi Medical College at 1 site in Pakistan.
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 3 inclusion and 3 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 5 Jul 2023. 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 Pakistan. 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.
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) (time frame: 5 years). 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 NCT05931042, 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 5 Jul 2023.