Clinical trial · Interventional

Neoadjuvant Goserelin for Triple Negative Breast Cancer

Prospective Phase II Randomized Trial of Evaluating the Effect of Adding LHRH Analogue to the Neoadjuvant Chemotherapy Treatment of Triple Negative Breast Cancer on Pathologic Complete Response (pCR) Rates

NCT03444025CI-TRIAL-00031778NeoGONTunknownPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This is a phase II randomized trial that will evaluate the effect of adding LHRH analogue, goserelin, to the standard neoadjuvant chemotherapy to patients with triple negative breast cancer. Targeting LHRH might decrease resistance to chemotherapeutic agents in the neoadjuvant setting and increases clinical and pathological response rates. Additionally, exploring potential surrogate markers (as AR and LHRH receptors) for molecular distinct subtypes of TNBC.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer Triple Negative	Triple-Negative Breast Carcinoma	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Goserelin	Drug	Goserelin	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Group A
description
Goserelin 3.6 mg depot injection will be administered subcutaneously every month along with standard chemotherapy regimen: AC-P: Doxorubicin 60 mg/m2 IV plus cyclophosphamide 600 mg/m2 every 3 weeks for four cycles, followed by paclitaxel 80 mg/m2 by 1 hour infusion every week for 12 weeks. Each cycle is 21 days.
interventionNames
1. Drug: Goserelin
type
NO_INTERVENTION
label
Group B
description
Standard chemotherapy regimen: AC-P: Doxorubicin 60 mg/m2 IV plus cyclophosphamide 600 mg/m2 every 3 weeks for four cycles, followed by paclitaxel 80 mg/m2 by 1 hour infusion every week for 12 weeks. Each cycle is 21 days.

Primary outcomes (1)

measure
pathologic complete response rate
timeFrame
6 months

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years

Show eligibility criteria text

Inclusion Criteria:

1. Premenopausal women between 18 and 60 years.
2. Histologically proven, newly diagnosed invasive carcinoma of breast.
3. Tumors must be ER, PgR negative and HER2-neu negative.
4. Stage II or III breast cancer that is indicated for neoadjuvant systemic chemotherapy.

Exclusion Criteria:

1. pregnant females at time of diagnosis of breast cancer.
2. bilateral breast cancer.
3. already received treatment for breast cancer including surgery, radiation, cytotoxic, or endocrine therapy
4. history or concomitant diagnosis of another primary malignancy.
5. concurrent treatment with oral contraceptives or hormone replacement therapy (OCPs or HRT must be stopped at least 4 weeks prior to randomization).

References

Publications (0)

Data not yet available

No reference posted for this study.