18 and older, female only, with Breast Cancer or Estrogen Receptor Positive Tumor. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pathological Complete Response (pCR)Primary· Assessed within 30 days of the time of breast surgery after completion of a treatment period of up to 16 weeks; up to 21 weeks. If the patient does not undergo surgery, assessment will occur within 30 days after all treatment is stopped; up to 30 weeks.
Pathological complete response (pCR) is defined as absence of invasive tumour cells in the breast and in the axillary lymph nodes at the time of surgery (ypT0/ypTis ypN0) determined from the local histopathologic evaluation according to the American Joint Committee on Cancer Staging Manual. The presence of in situ cancer after trial treatment in the absence of residual invasive disease constitutes a pCR.
Group
Value
95% CI
Paclitaxel Plus Trastuzumab and Pertuzumab
24
Palbociclib Plus Letrozole Plus Trastuzumab and Pertuzumab
24
Pathological Complete Response (pCR) in the BreastSecondary· Assessed within 30 days of the time of breast surgery after completion of a treatment period of up to 16 weeks; up to 21 weeks. If the patient does not undergo surgery, assessment will occur within 30 days after all treatment is stopped; up to 30 weeks.
Defined as the absence of invasive tumour cells in the breast at the time of surgery (ypT0/ypTis) determined from the local histopathologic evaluation according to the American Joint Committee on Cancer Staging Manual..
Group
Value
95% CI
Paclitaxel Plus Trastuzumab and Pertuzumab
26
Palbociclib Plus Letrozole Plus Trastuzumab and Pertuzumab
25
Objective ResponseSecondary· Tumor assessments were performed by ultrasound and mammography at screening (prior to treatment start), and before surgery; measurements by caliper were assessed at the same time points and at the end of cycle 2 (28 days/cycle), approximately 56 days.
The number of patients with partial or complete response measured physically by caliper and by ultrasound and mammography. Response was assessed using World Health Organization tumor measurement and response criteria.
Complete response (CR) - The disappearance of all known disease. Partial response (PR) - A 50% or more decrease in total tumor size, i.e., the sum of the products of the maximal diameter (MD) and the corresponding largest perpendicular diameter (LPD) of the lesions which have been measured to determine the effect of therapy. In addition, there can be no appearance of new lesions
Group
Value
95% CI
Paclitaxel Plus Trastuzumab and Pertuzumab
35
Palbociclib Plus Letrozole Plus Trastuzumab and Pertuzumab
38
Paclitaxel Plus Trastuzumab and Pertuzumab
17
Palbociclib Plus Letrozole Plus Trastuzumab and Pertuzumab
19
Paclitaxel Plus Trastuzumab and Pertuzumab
4
Palbociclib Plus Letrozole Plus Trastuzumab and Pertuzumab
4
Paclitaxel Plus Trastuzumab and Pertuzumab
3
Palbociclib Plus Letrozole Plus Trastuzumab and Pertuzumab
2
Rate of Breast Conserving Surgery (BCS)Secondary· From randomization until completion of study, up to 20 months
Defined as the number of patients undergoing BCS, divided by the number of patients in the assessable population (subset of the randomized population with RBsig status successfully determined who received at least 1 dose of medication).
Group
Value
95% CI
Paclitaxel Plus Trastuzumab and Pertuzumab
49
Palbociclib Plus Letrozole Plus Trastuzumab and Pertuzumab
59
Adverse events — posted to ClinicalTrials.gov
Time frame: Assessed at the end of every 4-week cycle until the end of trial treatment prior to surgery; up to 20 weeks. Only serious adverse events were assessed 30 days after end of treatment; up to 21 weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Paclitaxel Plus Trastuzumab and Pertuzumab
Serious: 23/73 (32%)
Deaths: 0/73
Palbociclib Plus Letrozole Plus Trastuzumab and Pertuzumab
This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in combination with HER2 blockade.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ETOP IBCSG Partners Foundation
Last refreshed: 13 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03644186.